Bioequivalence Study of Fixed Dose Versus Single Entities... | NCT03078556 | Trialant
NCT03078556
Sponsor
ViiV Healthcare
Status
Completed
Last Update Posted
Feb 21, 2019Actual
Enrollment
154Actual
Phase
Phase 1
Conditions
Infection, Human Immunodeficiency Virus
Interventions
Dolutegravir
Lamivudine
Dolutegravir + Lamivudine FDC Formulation 1
Dolutegravir + Lamivudine FDC Formulation 2
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT03078556
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
204994
Secondary IDs
Not provided
Brief Title
Bioequivalence Study of Fixed Dose Versus Single Entities of Dolutegravir and Lamivudine
Official Title
An Open-label, Randomized, Single Dose, Crossover, Pivotal Bioequivalence Study of Fixed-dose Combination Tablets of Dolutegravir and Lamivudine Versus Dolutegravir and Lamivudine Single Entities and Food Effect Assessment in Healthy Volunteers
Acronym
Not provided
Organization
ViiV HealthcareINDUSTRY
Status Module
Record Verification Date
Aug 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 27, 2017Actual
Primary Completion Date
Aug 18, 2017Actual
Completion Date
Aug 18, 2017Actual
First Submitted Date
Mar 8, 2017
First Submission Date that Met QC Criteria
Mar 8, 2017
First Posted Date
Mar 13, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Aug 10, 2018
Results First Submitted that Met QC Criteria
Oct 10, 2018
Results First Posted Date
Feb 21, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 10, 2018
Last Update Posted Date
Feb 21, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ViiV HealthcareINDUSTRY
Collaborators
Name
Class
GlaxoSmithKline
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study aims to compare the bioequivalence of two experimental fixed dose combination (FDC) tablets versus single entity products of dolutegravir (DTG) and lamivudine (3TC) in healthy adult subjects. The study will be carried out in two parts. Part 1 of the study will be open label, up to 3 periods design with a wash out period of at least 7 days between treatment periods. Subjects will be randomized to receive either single entities or formulation 1 FDC of DTG and 3TC in a crossover manner in first 2 periods. The first 16 subjects who complete the first two treatment periods and consent to continue will receive a single dose of FDC formulation 1 tablet administered with a high fat meal for a third treatment period. In Part 2 of the study, subjects will be randomized to receive either single entities or formulation 2 FDC of DTG and 3TC in a crossover manner in first 2 periods. Similarly the first 16 subjects will then receive FDC formulation 2 tablets with high fat meal in treatment period 3. Subjects will have a follow-up visit within 7-14 days after the last dose of study drug. Approximately 76 healthy subjects will be included in Part 1 of the study and if Part 2 of the study is conducted, another 76 healthy subjects will be included. The total duration will be approximately 11 weeks.
Detailed Description
Not provided
Conditions Module
Conditions
Infection, Human Immunodeficiency Virus
Keywords
FDC
Lamivudine
Bio-equivalence
Dolutegravir
HIV
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
154Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Treatment sequence A/B: Part 1
Experimental
Eligible subjects will be randomized in sequence A/B and will receive A: DTG 50 milligram (mg) and 3TC 300 mg single entities in Period 1, B: DTG 3TC FDC formulation 1 tablet in Period 2.
Drug: Dolutegravir
Drug: Lamivudine
Drug: Dolutegravir + Lamivudine FDC Formulation 1
Treatment sequence B/A: Part 1
Experimental
Eligible subjects will be randomized in sequence B/A and will receive B: DTG 3TC FDC formulation 1 tablet in Period 1 and A: DTG 50 mg and 3TC 300 mg single entities in Period 2.
Drug: Dolutegravir
Drug: Lamivudine
Drug: Dolutegravir + Lamivudine FDC Formulation 1
Subjects receiving high fat meal: Part 1
Experimental
Eligible subjects will be administered single dose of DTG 3TC FDC formulation 1 tablet with high fat meal in Period 3 to study the effect of food on tablet.
Drug: Dolutegravir + Lamivudine FDC Formulation 1
Treatment sequence A/C: Part 2
Experimental
Eligible subjects will be randomized in sequence A/B and will receive A: DTG 50 mg and 3TC 300 mg single entities in Period 1 and C: DTG 3TC FDC formulation 2 tablet in Period 2.
Drug: Dolutegravir
Drug: Lamivudine
Drug: Dolutegravir + Lamivudine FDC Formulation 2
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Dolutegravir
Drug
Single dose of DTG 50 mg tablet along with 3TC (EPIVIR) tablet will be given to randomized subjects in parts 1 and 2 with 240 mL of room temperature water. DTG will be a white, film coated, round tablet engraved with SV 572 on one side and 50 on the other side.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity [AUC (0-Inf)] of Plasma DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the pharmacokinetic (PK) profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
AUC (0-Inf) of Plasma DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at given time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted conditions in Periods 1 and 2 of Part 2.
Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Time Point (AUC[0-t]) of Plasma DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Absorption Lag Time (Tlag) of DTG and 3TC in Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Between 18 and 55 years of age inclusive, at the time of signing the informed consent.
Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac evaluation (history, electrocardiogram [ECG]).
A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical Monitor if required, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Subject must be able to swallow 2 tablets at the same time (Reference tablets only).
Body weight >=50 kilogram (kg) for men and >=45 kg for women and body mass index (BMI) within the range 18.5-31.0 kg per meter square (kg/m^2).
Male or Female. Female subject: is eligible to participate if she is not pregnant (as confirmed by a negative serum or urine human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies: 1. non-reproductive potential defined as: pre-menopausal females with one of the following: documented tubal ligation; documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; hysterectomy; documented bilateral Oophorectomy. Postmenopausal defined as 12 months of spontaneous amenorrhea; in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. 2. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication and until at least five terminal half-lives OR until any continuing pharmacologic effect has ended, whichever is longer after the last dose of study medication and completion of the follow-up visit.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions.
Exclusion Criteria:
Alanine aminotransferase (ALT) and bilirubin >1.5x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percentage).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
QT interval corrected for heart rate according to Fridericia's formula (QTcF) > 450 milliseconds (msec).
Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and ViiV Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 gram (g) of alcohol: 12 ounces [360 milliliter (mL)] of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 1 month prior to screening.
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
Creatinine clearance (CrCL) <90 mL/minute.
A positive hepatitis B surface antigen (HBsAg) or a positive hepatitis B core antibody with a negative hepatitis B surface antibody, positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
A positive pre-study drug/alcohol screen.
A positive test for HIV antibody.
Where participation in the study would result in donation of blood or blood product in excess of 500 mL within 56 days.
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
55 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
GSK Clinical Trials
ViiV Healthcare
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
GSK Investigational Site
Overland Park
Kansas
66211
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
A total of 283 (Part 1: 150, Part 2: 133) participants were screened for this study; 125 (Part 1: 72, Part2: 53) participants were screen failures (SF) and 4 participants were reserved but not used. The reasons for SF: inclusion/exclusion criteria not met (105), withdrew consent (18), physician decision (2).
Recruitment Details
The study was conducted in 2 parts (Part 1 and Part 2) at a single center in the United States from 27-March-2017 to 18-August-2017 and 154 participants (78 in Part 1 and 76 in Part 2) were randomized. First 16 participants completing the first 2 dosing periods, returned for a 3rd treatment period and received single dose of FDC with high fat meal
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1:DTG+EPIVIR/DTG+3TC Monolayer/DTG+3TC Monolayer-fed
Participants were randomized to receive dolutegravir (DTG) 50 milligram (mg) tablet plus a single lamivudine (3TC) tablet in Period 1 followed by DTG 50 mg/3TC 300 mg fixed dose combination (FDC) monolayer formulation in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC monolayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods.
FG001
Part 1:DTG+3TC Monolayer/DTG+EPIVIR/DTG+3TC Monolayer-fed
Participants were randomized to receive DTG 50 mg/3TC 300 mg FDC monolayer formulation in Period 1 followed by DTG 50 mg tablet plus a single 3TC tablet in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC monolayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods.
FG002
Part 2:DTG+EPIVIR/DTG+3TC Bilayer/DTG+3TC Bilayer-fed
Participants were randomized to receive DTG 50 mg tablet plus a single 3TC tablet in Period 1 followed by DTG 50 mg/3TC 300 mg FDC bilayer formulation in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC bilayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods.
FG003
Part 2:DTG+3TC Bilayer/DTG+EPIVIR /DTG+3TC Bilayer-fed
Participants were randomized to receive DTG 50 mg/3TC 300 mg FDC bilayer formulation in Period 1 followed by DTG 50 mg tablet plus a single 3TC tablet in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC bilayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods.
Periods
Title
Milestones
Reasons Not Completed
Treatment Period 1 (4 Days)
Type
Comment
Milestone Data
STARTED
FG00039 subjects
FG00139 subjects
FG00238 subjects
FG00338 subjects
COMPLETED
FG00039 subjects
FG00138 subjects
FG00238 subjects
FG00338 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG003
Washout Period 1 (7 Days)
Type
Comment
Milestone Data
STARTED
FG00039 subjects
FG00138 subjects
FG00238 subjects
FG003
Treatment Period 2 (4 Days)
Type
Comment
Milestone Data
STARTED
FG00037 subjects
FG00136 subjects
FG00237 subjects
FG003
Washout Period 2 (7 Days)
Type
Comment
Milestone Data
STARTED
FG0009 subjects
FG0017 subjects
FG0027 subjects
FG003
Treatment Period 3 (4 Days)
Type
Comment
Milestone Data
STARTED
FG0009 subjects
FG0017 subjects
FG0027 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Safety Population: All participants who enrolled in the study and received at least one dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1
Participants were randomized into treatment sequence A/B (treatment A in Period 1 followed by B in Period 2) or B/A (treatment B in Period 1 followed by A in Period 2), where A=dolutegravir (DTG) 50 milligram (mg) tablet plus a single lamivudine (3TC) tablet and treatment B= DTG 50 mg/3TC 300 mg fixed dose combination (FDC) monolayer formulation. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC monolayer tablet formulation administered with a high fat meal in Period 3. There was a washout period of at least 7 days between each treatment period. In treatment periods 1 and 2, single dose of the treatments were administered in the fasted state.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity [AUC (0-Inf)] of Plasma DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the pharmacokinetic (PK) profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
PK Parameter Bioequivalence (BE) Summary Population comprised of all participants who have evaluable PK parameters for both analytes and for both Period 1 and Period 2.
AEs and SAEs were collected from the start of study treatment until the follow-up contact (Up to 11 weeks)
Description
Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Eligible subjects will be randomized in sequence C/A and will receive C: DTG 3TC FDC formulation 2 tablet in Period 1 and A: DTG 50 milligram (mg) and 3TC 300 mg single entities in Period 2.
Drug: Dolutegravir
Drug: Lamivudine
Drug: Dolutegravir + Lamivudine FDC Formulation 2
Subjects receiving high fat meal: Part 2
Experimental
Eligible subjects will be administered single dose of DTG 3TC FDC formulation 2 tablet with high fat meal in Period 3 to study the effect of food on tablet.
Drug: Dolutegravir + Lamivudine FDC Formulation 2
Treatment sequence A/B: Part 1
Treatment sequence A/C: Part 2
Treatment sequence B/A: Part 1
Treatment sequence C/A: Part 2
Lamivudine
Drug
Single dose 3TC (commercial name: EPIVIR) 300 mg tablet along with DTG tablet will be given to randomized subjects in parts 1 and 2 with 240 mL of room temperature water.<br>3TC will be gray, diamond shaped tablet, engraved "GX EJ7" on one side and plain on the other side.
Treatment sequence A/B: Part 1
Treatment sequence A/C: Part 2
Treatment sequence B/A: Part 1
Treatment sequence C/A: Part 2
Dolutegravir + Lamivudine FDC Formulation 1
Drug
Single dose of DTG 50 mg combined with 3TC 300 mg in a FDC formulation 1 tablet will be administered to randomized subjects in treatment periods 1 and 2 (under fasted state) of Part 1 and the first 16 subjects in treatment period 3 (under fed) of Part 1 with 240 mL of room temperature water. <br>FDC formulation 1 tablets will be oval, biconvex, white, film coated tablet engraved 'SV H7I' on one face.
Subjects receiving high fat meal: Part 1
Treatment sequence A/B: Part 1
Treatment sequence B/A: Part 1
Dolutegravir + Lamivudine FDC Formulation 2
Drug
Single dose of DTG 50 mg combined with 3TC 300 mg in a FDC formulation 2 tablet will be administered to randomized subjects in treatment periods 1 and 2 (under fasted state) and the first 16 subjects in treatment period 3 (under fed) of Part 2 with 240 mL of room temperature water. <br>FDC formulation 2 tablets will be oval, biconvex, white, film coated tablet engraved 'SV 13N' on one face.
Subjects receiving high fat meal: Part 2
Treatment sequence A/C: Part 2
Treatment sequence C/A: Part 2
AUC(0-t) of Plasma DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Maximum Observed Concentration (Cmax) of Plasma DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Cmax of Plasma DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Time to Reach Maximum Plasma Concentration (Tmax) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2
Time of the Last Quantifiable Concentration (Tlast) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2
Time to Reach Half the Maximum Plasma Concentration (t1/2) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2
Apparent Elimination Rate Constant (Lambda z) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Lambda z of DTG and 3TC in in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Percentage of Extrapolated AUC (0 to Inf) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Percentage of Extrapolated AUC(0 to Inf) of DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
AUC of 0 to 24 Hours (AUC[0-24]) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
AUC(0-24) of DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Apparent Oral Clearance (CL/F) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Apparent Oral Volume of Distribution (Vz/F) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Concentration at 24 Hours Post-dose (C24) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Last Quantifiable Concentration (Clast) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Cmax of Plasma DTG and 3TC in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Cmax of Plasma DTG and 3TC in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Lambda z of DTG and 3TC in in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Lambda z of DTG and 3TC in in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2
SBP and DBP were measured in the supine or semi-supine position after 5 minutes rest. The Baseline value was considered to be the participant's last available assessment prior to time of the first dose. Change from Baseline was defined as post dose visit value minus Baseline value. Data for SBP and DBP for Part 1 and 2 is presented.
Up to Day 31 in Part 1 and Part 2
Change From Baseline in Heart Rate (HR): Part 1 and 2
HR was measured in the supine or semi-supine position after 5 minutes rest. The Baseline value was considered to be the participant's last available assessment prior to time of the first dose. Change from Baseline was defined as post dose visit value minus Baseline value. Data for HR for Part 1 and 2 is presented.
Up to Day 31 in Part 1 and Part 2
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1 and 2
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Participants having any AE or SAE are presented.
Up to Week 11
0 subjects
38 subjects
COMPLETED
FG00037 subjects
FG00136 subjects
FG00237 subjects
FG00337 subjects
NOT COMPLETED
FG0002 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
37 subjects
COMPLETED
FG00037 subjects
FG00136 subjects
FG00237 subjects
FG00337 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
9 subjects
COMPLETED
FG0009 subjects
FG0017 subjects
FG0027 subjects
FG0039 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
9 subjects
COMPLETED
FG0009 subjects
FG0017 subjects
FG0027 subjects
FG0039 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
BG001
Part 2
Participants were randomized into treatment sequence A/C (treatment A in Period 1 followed by C in Period 2) or C/A (treatment C in Period 1 followed by A in Period 2), where A=DTG 50 mg tablet plus a single 3TC tablet and treatment C= DTG 50 mg/3TC 300 mg FDC bilayer formulation. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC bilayer tablet formulation administered with a high fat meal in Period 3. There was a washout period of at least 7 days between each treatment period.
BG002
Total
Total of all reporting groups
78
BG00176
BG002154
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00029.4± 9.37
BG00131.6± 11.18
BG00230.5± 10.33
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00025
BG00126
BG00251
Male
BG00053
BG00150
BG002103
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
BG0006
BG0011
BG0027
Asian- Central/South Asian Heritage
Title
Measurements
BG0001
BG0011
BG0022
Asian- East Asian Heritage
Title
Measurements
BG0000
BG0011
BG0021
Asian- South East Asian Heritage
Title
Measurements
BG0001
BG0010
BG0021
Black or African American
Title
Measurements
BG00020
BG00123
BG00243
White-White/Caucasian/European Heritage
Title
Measurements
BG00050
BG00150
BG002100
A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00073
OG00173
Title
Denominators
Categories
DTG
Title
Measurements
OG00043.1456± 39.29
OG00154.8793± 31.60
3TC
Title
Measurements
OG00012.3337± 19.88
OG00112.7603± 19.77
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
1.2710
2-Sided
90
1.1894
1.3582
Ratio (B/A) of plasma DTG has been presented.
Other
OG000
OG001
Ratio
1.0341
2-Sided
90
1.0097
1.0591
Ratio (B/A) of plasma 3TC has been presented.
Other
Primary
AUC (0-Inf) of Plasma DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at given time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted conditions in Periods 1 and 2 of Part 2.
PK Parameter BE Summary Population. Only those participants with data available at the specified data points were analyzed, represented by n= X,X in the category titles.
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00074
OG00174
Title
Denominators
Categories
DTG, n= 74,74
ParticipantsOG00074
ParticipantsOG00174
Title
Measurements
OG00047.2391± 40.29
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
1.1550
2-Sided
90
1.0699
1.2468
Ratio (C/A) of plasma DTG has been presented.
Other
OG000
OG001
Primary
Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Time Point (AUC[0-t]) of Plasma DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00073
OG00173
Title
Denominators
Categories
DTG
Title
Measurements
OG00041.4207± 39.36
OG00152.8754± 31.16
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
1.2756
2-Sided
90
1.1919
1.3651
Ratio (B/A) of plasma DTG has been presented.
Other
OG000
OG001
Primary
AUC(0-t) of Plasma DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00074
OG00174
Title
Denominators
Categories
DTG
Title
Measurements
OG00045.2043± 39.57
OG00152.3372± 31.46
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
1.1578
2-Sided
90
1.0718
1.2507
Ratio (C/A) of plasma DTG has been presented.
Other
OG000
OG001
Primary
Maximum Observed Concentration (Cmax) of Plasma DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00073
OG00173
Title
Denominators
Categories
DTG
Title
Measurements
OG0002.4065± 38.95
OG0013.0817± 31.86
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
1.2805
2-Sided
90
1.1890
1.3790
Ratio (B/A) of plasma DTG has been presented.
Other
OG000
OG001
Primary
Cmax of Plasma DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
B: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50mg and 3TC 300mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00074
OG00174
Title
Denominators
Categories
DTG
Title
Measurements
OG0002.5531± 36.38
OG0012.9132± 30.55
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
1.1410
2-Sided
90
1.0533
1.2361
Ratio (C/A) of plasma DTG has been presented.
Other
OG000
OG001
Secondary
Absorption Lag Time (Tlag) of DTG and 3TC in Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00073
OG00173
Title
Denominators
Categories
DTG
Title
Measurements
OG0000.0000(0.0000 to 0.756)
OG0010.0000(0.0000 to 0.261)
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Median Difference (Final Values)
0.000
2-Sided
90
0.000
0.000
Median Difference of plasma DTG has been presented.
Other
OG000
OG001
Secondary
Tlag of DTG and 3TC in Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00074
OG00174
Title
Denominators
Categories
DTG
Title
Measurements
OG0000.0000(0.0000 to 0.261)
OG0010.0000(0.0000 to 0.266)
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Median Difference (Final Values)
0.000
2-Sided
90
-0.004
0.000
Median Difference of plasma DTG has been presented.
Other
OG000
OG001
Secondary
Time to Reach Maximum Plasma Concentration (Tmax) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00073
OG00173
Title
Denominators
Categories
DTG
Title
Measurements
OG0002.0072(0.500 to 8.009)
OG0012.0017(0.500 to 5.012)
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Median Difference (Final Values)
-0.127
2-Sided
90
-0.500
0.248
Median Difference of plasma DTG has been presented.
Other
OG000
OG001
Secondary
Tmax of DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00074
OG00174
Title
Denominators
Categories
DTG
Title
Measurements
OG0002.5008(0.500 to 5.011)
OG0012.5004(0.500 to 6.001)
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Median Difference (Final Values)
-0.127
2-Sided
90
-0.497
0.132
Median Difference of plasma DTG has been presented.
Other
OG000
OG001
Secondary
Time of the Last Quantifiable Concentration (Tlast) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00073
OG00173
Title
Denominators
Categories
DTG
Title
Measurements
OG00072.0031(48.000 to 74.636)
OG00171.9303(48.003 to 76.236)
3TC
Title
Measurements
OG000
Secondary
Tlast of DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00074
OG00174
Title
Denominators
Categories
DTG
Title
Measurements
OG00071.6813(48.006 to 75.301)
OG00171.8243(71.005 to 72.632)
3TC
Title
Measurements
OG000
Secondary
Time to Reach Half the Maximum Plasma Concentration (t1/2) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00073
OG00173
Title
Denominators
Categories
DTG
Title
Measurements
OG00014.6917(10.575 to 21.375)
OG00114.7557(10.461 to 21.392)
3TC
Title
Measurements
OG000
Secondary
t1/2 of DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2
PK Parameter BE Summary Population. Only those participants with data available at the specified time points were analyzed indicated by n=X in category titles.
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00074
OG00174
Title
Denominators
Categories
DTG, n= 74,74
ParticipantsOG00074
ParticipantsOG00174
Title
Measurements
OG00015.1538(9.711 to 21.966)
Secondary
Apparent Elimination Rate Constant (Lambda z) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00073
OG00173
Title
Denominators
Categories
DTG
Title
Measurements
OG0000.0472(0.032 to 0.066)
OG0010.0470(0.032 to 0.066)
3TC
Title
Measurements
OG000
Secondary
Lambda z of DTG and 3TC in in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
PK Parameter BE Summary Population. Only those participants with data available at the specified data points were analyzed (represented by n= X,X in the category titles).
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00074
OG00174
Title
Denominators
Categories
DTG, n=74,74
ParticipantsOG00074
ParticipantsOG00174
Title
Measurements
OG0000.0457(0.032 to 0.071)
Secondary
Percentage of Extrapolated AUC (0 to Inf) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00073
OG00173
Title
Denominators
Categories
DTG
Title
Measurements
OG0003.4967(1.015 to 15.084)
OG0013.2582(0.908 to 9.967)
3TC
Title
Measurements
OG000
Secondary
Percentage of Extrapolated AUC(0 to Inf) of DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
PK Parameter BE Summary Population. Only those participants with data available at the specified time points were analyzed indicated by n=X in category titles.
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00074
OG00174
Title
Denominators
Categories
DTG, n= 74,74
ParticipantsOG00074
ParticipantsOG00174
Title
Measurements
OG0003.8923(0.932 to 10.512)
Secondary
AUC of 0 to 24 Hours (AUC[0-24]) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00073
OG00173
Title
Denominators
Categories
DTG
Title
Measurements
OG00029.4257± 38.40
OG00137.6112± 30.28
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
1.2774
2-Sided
90
1.1931
1.3676
Ratio (B/A) of plasma DTG has been presented.
Other
OG000
OG001
Secondary
AUC(0-24) of DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00074
OG00174
Title
Denominators
Categories
DTG
Title
Measurements
OG00031.5664± 37.73
OG00136.6126± 30.93
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
1.1599
2-Sided
90
1.0711
1.2560
Ratio (C/A) of plasma DTG has been presented.
Other
OG000
OG001
Secondary
Apparent Oral Clearance (CL/F) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00073
OG00173
Title
Denominators
Categories
DTG
Title
Measurements
OG0001.1589± 39.29
OG0010.9111± 31.60
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
0.7868
2-Sided
90
0.7363
0.8408
Ratio (B/A) of plasma DTG has been presented.
Other
OG000
OG001
Secondary
CL/F of DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
PK Parameter BE Summary Population. Only those participants with data available at the specified time points were analyzed represented by n=X in the category titles.
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00074
OG00174
Title
Denominators
Categories
DTG, n= 74, 74
ParticipantsOG00074
ParticipantsOG00174
Title
Measurements
OG0001.0584± 40.29
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
0.8658
2-Sided
90
0.8021
0.9347
Ratio (C/A) of plasma DTG has been presented.
Other
OG000
OG001
Secondary
Apparent Oral Volume of Distribution (Vz/F) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00073
OG00173
Title
Denominators
Categories
DTG
Title
Measurements
OG00024.6254± 37.80
OG00119.3399± 30.05
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
0.7859
2-Sided
90
0.7318
0.8440
Ratio (B/A) of plasma DTG has been presented.
Other
OG000
OG001
Secondary
Vz/F of DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
PK Parameter BE Summary Population. Only those participants with data available at the specified data points were analyzed, represented by n= X,X in the category titles.
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00074
OG00174
Title
Denominators
Categories
DTG, n= 74, 74
ParticipantsOG00074
ParticipantsOG00174
Title
Measurements
OG00023.1159± 37.18
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
0.8571
2-Sided
90
0.7914
0.9282
Ratio (C/A) of plasma DTG has been presented.
Other
OG000
OG001
Secondary
Concentration at 24 Hours Post-dose (C24) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00073
OG00173
Title
Denominators
Categories
DTG
Title
Measurements
OG0000.6373± 40.18
OG0010.8059± 32.77
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
1.2632
2-Sided
90
1.1811
1.3511
Ratio (B/A) of plasma DTG has been presented.
Other
OG000
OG001
Secondary
C24 of DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00074
OG00174
Title
Denominators
Categories
DTG
Title
Measurements
OG0000.7065± 41.48
OG0010.8071± 33.83
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
1.1425
2-Sided
90
1.0597
1.2317
Ratio (C/A) of plasma DTG has been presented.
Other
OG000
OG001
Secondary
Last Quantifiable Concentration (Clast) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00073
OG00173
Title
Denominators
Categories
DTG
Title
Measurements
OG0000.0702± 58.85
OG0010.0832± 56.42
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
1.1839
2-Sided
90
1.0921
1.2834
Ratio (B/A) of plasma DTG has been presented
Other
OG000
OG001
Secondary
Clast of DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Units
Counts
Participants
OG00074
OG00174
Title
Denominators
Categories
DTG
Title
Measurements
OG0000.0800± 66.94
OG0010.0862± 65.26
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
1.0780
2-Sided
90
0.9958
1.1670
Ratio (B/A) of plasma DTG has been presented
Other
OG000
OG001
Secondary
AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
PK Parameter food effect (FD) Summary Population comprised of participants who participated in the food effect part of the study and had evaluable PK parameters for both fed and fasted administration of the FDC tablet formulation.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Bfed: DTG 50 mg/3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG00062.3435± 32.34
OG00171.9777± 19.99
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
1.1545
2-Sided
90
1.0208
1.3058
Ratio (Bfed/B) of plasma DTG has been presented
Other
OG000
OG001
Secondary
AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG00057.6561± 35.93
OG00176.4283± 22.36
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
1.3256
2-Sided
90
1.1837
1.4845
Ratio (Cfed/C) of plasma DTG has been presented
Other
OG000
OG001
Secondary
AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG00060.3212± 31.78
OG00169.2560± 18.92
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
1.1481
2-Sided
90
1.0154
1.2982
Ratio (Bfed/B) of plasma DTG has been presented
Other
OG000
OG001
Secondary
AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG00055.2176± 35.33
OG00172.7545± 20.22
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
1.3176
2-Sided
90
1.1750
1.4775
Ratio (Cfed/C) of plasma DTG has been presented
Other
OG000
OG001
Secondary
Cmax of Plasma DTG and 3TC in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG0003.5068± 30.27
OG0013.7900± 20.97
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
1.0808
2-Sided
90
0.9527
1.2261
Ratio (Bfed/B) of plasma DTG has been presented
Other
OG000
OG001
Secondary
Cmax of Plasma DTG and 3TC in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG0003.1015± 35.62
OG0013.7516± 21.31
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
1.2096
2-Sided
90
1.0521
1.3908
Ratio (Cfed/C) of plasma DTG has been presented
Other
OG000
OG001
Secondary
Tlag of DTG and 3TC in Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG0000.0000(0.0000 to 0.251)
OG0010.2522(0.0000 to 1.000)
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Median Difference (Final Values)
0.254
2-Sided
90
0.250
0.378
Median Difference of plasma DTG has been presented
Other
OG000
OG001
Secondary
Tlag of DTG and 3TC in Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG0000.0000(0.0000 to 0.258)
OG0010.1253(0.0000 to 0.751)
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Median Difference (Final Values)
0.126
2-Sided
90
0.000
0.250
Median Difference of plasma DTG has been presented
Other
OG000
OG001
Secondary
Tmax of DTG and 3TC in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG0001.5013(0.503 to 5.002)
OG0015.0006(2.001 to 12.009)
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Median Difference (Final Values)
3.017
2-Sided
90
1.872
4.496
Median Difference of plasma DTG has been presented
Other
OG000
OG001
Secondary
Tmax of DTG and 3TC in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG0001.5007(0.751 to 3.001)
OG0015.0019(1.011 to 8.004)
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Median Difference (Final Values)
2.500
2-Sided
90
1.748
3.751
Median Difference of plasma DTG has been presented
Other
OG000
OG001
Secondary
T1/2 of DTG and 3TC in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG00014.5843(12.077 to 16.806)
OG00114.5816(10.889 to 17.259)
3TC
Title
Measurements
OG000
Secondary
T1/2 of DTG and 3TC in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG00014.9828(11.355 to 20.563)
OG00115.1718(12.193 to 19.945)
3TC
Title
Measurements
OG000
Secondary
Lambda z of DTG and 3TC in in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG0000.0475(0.041 to 0.057)
OG0010.0475(0.040 to 0.064)
3TC
Title
Measurements
OG000
Secondary
Lambda z of DTG and 3TC in in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG0000.0463(0.034 to 0.061)
OG0010.0457(0.035 to 0.057)
3TC
Title
Measurements
OG000
Secondary
Clast of DTG and 3TC in in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG0000.1060(0.035 to 0.180)
OG0010.1190(0.043 to 0.243)
3TC
Title
Measurements
OG000
Secondary
Clast of DTG and 3TC in in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG0000.0975(0.031 to 0.240)
OG0010.1310(0.051 to 0.363)
3TC
Title
Measurements
OG000
Secondary
Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG0003.3305(1.490 to 4.845)
OG0013.8870(1.094 to 6.134)
3TC
Title
Measurements
OG000
Secondary
Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG0003.6835(1.069 to 8.601)
OG0013.8790(1.561 to 9.126)
3TC
Title
Measurements
OG000
Secondary
AUC(0-24) of DTG and 3TC in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG00043.1879± 29.88
OG00146.8555± 16.95
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
1.0849
2-Sided
90
0.9613
1.2245
Ratio (Bfed/B) of plasma DTG has been presented
Other
OG000
OG001
Secondary
AUC(0-24) of DTG and 3TC in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG00038.6325± 34.53
OG00148.2012± 15.53
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Median Difference (Final Values)
1.2477
2-Sided
90
1.1013
1.4136
Median Difference of plasma DTG has been presented
Other
OG000
OG001
Secondary
CL/F of DTG and 3TC in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG0000.8020± 32.34
OG0010.6947± 19.99
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
0.8661
2-Sided
90
0.7658
0.9796
Ratio (Bfed/B) of plasma DTG has been presented
Other
OG000
OG001
Secondary
CL/F of DTG and 3TC in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG0000.8672± 35.93
OG0010.6542± 22.36
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
0.7544
2-Sided
90
0.6736
0.8448
Ratio (Cfed/C) of plasma DTG has been presented
Other
OG000
OG001
Secondary
Tlast of DTG and 3TC in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG00071.8265(71.124 to 72.301)
OG00171.9758(71.330 to 72.869)
3TC
Title
Measurements
OG000
Secondary
Tlast of DTG and 3TC in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG00072.0292(71.446 to 72.269)
OG00171.8711(71.080 to 72.381)
3TC
Title
Measurements
OG000
Secondary
Vz/F of DTG and 3TC in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG00016.7520± 28.45
OG00114.4964± 15.87
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
0.8654
2-Sided
90
0.7629
0.9816
Ratio (Bfed/B) of plasma DTG has been presented
Other
OG000
OG001
Secondary
Vz/F of DTG and 3TC in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG00019.0954± 36.45
OG00114.6215± 11.63
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
0.7657
2-Sided
90
0.6702
0.8749
Ratio (Cfed/C) of plasma DTG has been presented
Other
OG000
OG001
Secondary
C24 of DTG and 3TC in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG0000.9216± 36.08
OG0011.1916± 25.03
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
1.2929
2-Sided
90
1.1281
1.4819
Ratio (Bfed/B) of plasma DTG has been presented
Other
OG000
OG001
Secondary
C24 of DTG and 3TC in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
DTG
Title
Measurements
OG0000.8355± 38.46
OG0011.2273± 25.73
3TC
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio
1.4690
2-Sided
90
1.3009
1.6588
Ratio (Cfed/C) of plasma DTG has been presented
Other
OG000
OG001
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2
SBP and DBP were measured in the supine or semi-supine position after 5 minutes rest. The Baseline value was considered to be the participant's last available assessment prior to time of the first dose. Change from Baseline was defined as post dose visit value minus Baseline value. Data for SBP and DBP for Part 1 and 2 is presented.
Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug. Only those participants available at the specified time points were analyzed represented by n=X,X,X,X,X,X in the category titles.
Posted
Mean
Standard Deviation
Millimeters of mercury
Up to Day 31 in Part 1 and Part 2
ID
Title
Description
OG000
Part 1- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Part 1- B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG002
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
OG003
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG004
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG005
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Units
Counts
Participants
OG00075
OG00176
OG00216
OG003
Title
Denominators
Categories
DBP,4 hour,n=75,76,16,75,75,16
ParticipantsOG00075
ParticipantsOG00176
ParticipantsOG00216
ParticipantsOG003
Secondary
Change From Baseline in Heart Rate (HR): Part 1 and 2
HR was measured in the supine or semi-supine position after 5 minutes rest. The Baseline value was considered to be the participant's last available assessment prior to time of the first dose. Change from Baseline was defined as post dose visit value minus Baseline value. Data for HR for Part 1 and 2 is presented.
Safety Population. Only those participants available at the specified time points were analyzed represented by n=X,X,X,X,X,X in the category titles.
Posted
Mean
Standard Deviation
Beats per minute
Up to Day 31 in Part 1 and Part 2
ID
Title
Description
OG000
Part 1- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Part 1- B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG002
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
OG003
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG004
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG005
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Units
Counts
Participants
OG00075
OG00176
OG00216
OG003
Title
Denominators
Categories
4 hour,n=75,76,16,75,75,16
ParticipantsOG00075
ParticipantsOG00176
ParticipantsOG00216
ParticipantsOG003
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1 and 2
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Participants having any AE or SAE are presented.
Safety Population.
Posted
Count of Participants
Participants
Up to Week 11
ID
Title
Description
OG000
Part 1- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG001
Part 1- B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG002
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
OG003
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG004
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
OG005
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Units
Counts
Participants
OG00075
OG00176
OG00216
OG003
Title
Denominators
Categories
AEs
Title
Measurements
OG00014
OG00118
OG0021
OG003
0
75
0
75
2
75
EG001
Part 1- B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
0
76
0
76
5
76
EG002
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
0
16
0
16
1
16
EG003
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
0
75
0
75
8
75
EG004
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
0
75
0
75
6
75
EG005
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
0
16
0
16
1
16
EG0002 affected75 at risk
EG0015 affected76 at risk
EG0021 affected16 at risk
EG0038 affected75 at risk
EG0046 affected75 at risk
EG0050 affected16 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 affected75 at risk
EG0010 affected76 at risk
EG0020 affected16 at risk
EG0030 affected75 at risk
EG0040 affected75 at risk
EG0051 affected16 at risk
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 affected75 at risk
EG0010 affected76 at risk
EG0020 affected16 at risk
EG0030 affected75 at risk
EG0040 affected75 at risk
EG0051 affected16 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
D012749
Sexually Transmitted Diseases
D016180
Lentivirus Infections
D012192
Retroviridae Infections
D012327
RNA Virus Infections
D014777
Virus Diseases
D012897
Slow Virus Diseases
D000091662
Genital Diseases
D000091642
Urogenital Diseases
D007153
Immunologic Deficiency Syndromes
D007154
Immune System Diseases
D011743
Pyrimidines
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D003853
Deoxyribonucleosides
D009705
Nucleosides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
D015224
Dideoxynucleosides
OG00154.5594± 32.12
3TC, n= 73,74
ParticipantsOG00073
ParticipantsOG00174
Title
Measurements
OG00012.7713± 18.63
OG00113.5624± 17.94
Ratio
1.0635
2-Sided
90
1.0413
1.0861
Ratio (C/A) of plasma 3TC has been presented.
Other
12.1571
± 20.19
OG00112.6147± 19.75
Ratio
1.0372
2-Sided
90
1.0116
1.0634
Ratio (B/A) of plasma 3TC has been presented.
Other
12.4790
± 19.19
OG00113.3552± 18.10
Ratio
1.0702
2-Sided
90
1.0464
1.0946
Ratio (C/A) of plasma 3TC has been presented.
Other
2.6650
± 29.04
OG0013.1885± 28.07
Ratio
1.1956
2-Sided
90
1.1437
1.2498
Ratio (B/A) of plasma 3TC has been presented.
Other
2.4428
± 28.25
OG0013.2185± 29.30
Ratio
1.3176
2-Sided
90
1.2616
1.3760
Ratio (C/A) of plasma 3TC has been presented.
Other
0.0000
(0.0000 to 0.252)
OG0010.0000(0.0000 to 0.261)
Median Difference (Final Values)
0.000
2-Sided
90
0.000
0.000
Median Difference of plasma 3TC has been presented.
Other
0.0000
(0.0000 to 0.0000)
OG0010.0000(0.0000 to 0.252)
Median Difference (Final Values)
0.000
2-Sided
90
0.000
0.000
Median Difference of plasma 3TC has been presented.
Other
1.0047
(0.500 to 4.005)
OG0011.0008(0.500 to 3.500)
Median Difference (Final Values)
-0.126
2-Sided
90
-0.253
-0.001
Median Difference of plasma 3TC has been presented.
Other
1.0063
(0.500 to 4.002)
OG0011.0011(0.500 to 3.501)
Median Difference (Final Values)
-0.248
2-Sided
90
-0.376
-0.001
Median Difference of plasma 3TC has been presented.
Other
71.9289
(47.673 to 74.636)
OG00171.9303(70.790 to 76.236)
71.7138
(48.000 to 75.301)
OG00171.8153(48.007 to 72.632)
17.0395
(8.281 to 34.542)
OG00117.3436(12.436 to 34.675)
OG00114.7893(9.815 to 21.486)
3TC, n= 73,74
ParticipantsOG00073
ParticipantsOG00174
Title
Measurements
OG00017.8421(10.195 to 47.171)
OG00118.1071(7.367 to 48.613)
0.0407
(0.020 to 0.084)
OG0010.0400(0.020 to 0.056)
OG0010.0469(0.032 to 0.071)
3TC, n= 73,74
ParticipantsOG00073
ParticipantsOG00174
Title
Measurements
OG0000.0388(0.015 to 0.068)
OG0010.0383(0.014 to 0.094)
1.0287
(0.343 to 7.305)
OG0010.9052(0.428 to 5.334)
OG0013.5773(0.659 to 9.570)
3TC, n= 73,74
ParticipantsOG00073
ParticipantsOG00174
Title
Measurements
OG0001.2518(0.344 to 6.409)
OG0011.1432(0.394 to 7.867)
11.3960
± 20.92
OG00111.9418± 20.09
Ratio
1.0475
2-Sided
90
1.0185
1.0773
Ratio (B/A) of plasma 3TC has been presented.
Other
11.6419
± 20.23
OG00112.5810± 18.50
Ratio
1.0807
2-Sided
90
1.0539
1.1081
Ratio (C/A) of plasma 3TC has been presented.
Other
24.3236
± 19.88
OG00123.5104± 19.77
Ratio
0.9670
2-Sided
90
0.9442
0.9904
Ratio (B/A) of plasma 3TC has been presented.
Other
OG0010.9164± 32.12
3TC, n= 73, 74
ParticipantsOG00073
ParticipantsOG00174
Title
Measurements
OG00023.4901± 18.63
OG00122.1200± 17.94
Ratio
0.9403
2-Sided
90
0.9207
0.9604
Ratio (C/A) of plasma 3TC has been presented.
Other
616.7365
± 34.52
OG001598.8651± 29.07
Ratio
0.9704
2-Sided
90
0.9157
1.0284
Ratio (B/A) of plasma 3TC has been presented.
Other
OG00119.8124± 32.73
3TC, n= 73, 74
ParticipantsOG00073
ParticipantsOG00174
Title
Measurements
OG000650.7952± 35.55
OG001599.5525± 34.28
Ratio
0.9153
2-Sided
90
0.8613
0.9728
Ratio (C/A) of plasma 3TC has been presented.
Other
0.0331
± 32.13
OG0010.0318± 31.81
Ratio
0.9598
2-Sided
90
0.9268
0.9941
Ratio (B/A) of plasma 3TC has been presented.
Other
0.0366
± 30.39
OG0010.0350± 31.19
Ratio
0.9548
2-Sided
90
0.9299
0.9804
Ratio (C/A) of plasma 3TC has been presented.
Other
0.0056
± 43.03
OG0010.0050± 37.58
Ratio
0.8874
2-Sided
90
0.8340
0.9443
Ratio (B/A) of plasma 3TC has been presented
Other
0.0069
± 47.83
OG0010.0062± 41.60
Ratio
0.9049
2-Sided
90
0.8474
0.9663
Ratio (B/A) of plasma 3TC has been presented
Other
13.4357
± 21.02
OG00112.8668± 18.50
Ratio
0.9577
2-Sided
90
0.9126
1.0049
Ratio (Bfed/B) of plasma 3TC has been presented
Other
14.6420
± 18.50
OG00113.3443± 20.34
Ratio
0.9114
2-Sided
90
0.8658
0.9593
Ratio (Cfed/C) of plasma 3TC has been presented
Other
13.2818
± 20.90
OG00112.6491± 18.63
Ratio
0.9524
2-Sided
90
0.9086
0.9983
Ratio (Bfed/B) of plasma 3TC has been presented
Other
14.4706
± 18.72
OG00113.0923± 20.57
Ratio
0.9048
2-Sided
90
0.8592
0.9528
Ratio (Cfed/C) of plasma 3TC has been presented
Other
3.5413
± 27.14
OG0012.5132± 18.74
Ratio
0.7097
2-Sided
90
0.6474
0.7779
Ratio (Bfed/B) of plasma 3TC has been presented
Other
3.5824
± 35.18
OG0012.4453± 33.88
Ratio
0.6826
2-Sided
90
0.5861
0.7950
Ratio (Cfed/C) of plasma 3TC has been presented
Other
0.0000
(0.0000 to 0.251)
OG0010.0000(0.0000 to 0.255)
Median Difference (Final Values)
0.125
2-Sided
90
0.000
0.127
Median Difference of plasma 3TC has been presented
Other
0.0000
(0.0000 to 0.252)
OG0010.0000(0.0000 to 0.257)
Median Difference (Final Values)
0.000
2-Sided
90
0.000
0.125
Median Difference of plasma 3TC has been presented
Other
1.0001
(0.500 to 2.001)
OG0013.5003(1.011 to 5.006)
Median Difference (Final Values)
2.113
2-Sided
90
1.500
2.751
Median Difference of plasma 3TC has been presented
Other
1.0003
(0.503 to 2.506)
OG0012.7508(1.001 to 6.001)
Median Difference (Final Values)
1.503
2-Sided
90
0.998
2.252
Median Difference of plasma 3TC has been presented
Other
18.3614
(12.509 to 30.759)
OG00119.8579(9.977 to 34.144)
17.2250
(13.259 to 37.099)
OG00119.7311(13.384 to 27.781)
0.0378
(0.023 to 0.055)
OG0010.0349(0.020 to 0.069)
0.0403
(0.019 to 0.052)
OG0010.0351(0.025 to 0.052)
0.0048
(0.003 to 0.014)
OG0010.0066(0.004 to 0.016)
0.0059
(0.003 to 0.011)
OG0010.0091(0.003 to 0.015)
0.8856
(0.561 to 3.510)
OG0011.4830(0.788 to 4.324)
1.0443
(0.467 to 3.859)
OG0011.7467(0.567 to 3.642)
12.6113
± 21.25
OG00111.8076± 18.71
Ratio
0.9363
2-Sided
90
0.8913
0.9836
Ratio (Bfed/B) of plasma 3TC has been presented
Other
13.7012
± 19.24
OG00112.1065± 21.09
Median Difference (Final Values)
0.8836
2-Sided
90
0.8351
0.9350
Median Difference of plasma 3TC has been presented