| Primary | Area Under the Plasma Concentration-time Curve (AUC) From Time of Dose Extrapolated to Infinity (AUC[0-inf]) in Part 1 of DTG | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic (PK) parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. PK population comprised of participants in the all participants population (participants who took at least 1 dose of study medication) for whom PK sample was obtained and who had evaluable PK assay results. Statistics has been presented on geometric least square (LS) means. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00059.761± 31
- OG001101.125± 22
- OG00277.742± 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 |
|---|
| | | | | | Ratio of geometric LS means | 1.6946 | | | 2-Sided | 90 | 1.5690 | 1.8373 | | | Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented | | Other | | | | | |
|
| Primary | AUC From Time of Dose to Last Measurable Concentration (AUC[0-t]) in Part 1 of DTG | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | | Pre-dose,15 and 30 minutes,1 ,1.5 ,2 ,2.5 ,3 ,4 ,5 ,6 ,8 ,12 ,16 ,24 ,48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Primary | Maximum Observed Concentration (Cmax) in Part 1 of DTG in Plasma | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Primary | AUC(0-inf) in Part 1 of ABC | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Primary | AUC(0-t) in Part 1 of ABC | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Primary | Cmax in Part 1 of ABC in Plasma | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Primary | AUC(0-inf) in Part 1 of 3TC | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Primary | AUC (0-t) in Part 1 of 3TC | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Primary | Cmax in Part 1 of 3TC | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Primary | AUC(0-inf) in Part 2 of DTG in Plasma | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Primary | AUC(0-t) in Part 2 of DTG | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Primary | Cmax in Part 2 of DTG in Plasma | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Primary | AUC(0-inf) in Part 2 of 3TC | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Primary | AUC(0-t) in Part 2 of 3TC | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Primary | Cmax in Part 2 of 3TC | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | AUC From Time of Dose to 24 Hours (AUC[0-24]) of DTG in Part 1 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Time to Maximum Concentration (Tmax) of DTG in Plasma in Part 1 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Median | Full Range | Hours | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Time of Last Quantifiable Concentration (Tlast) of DTG in Part 1 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Median | Full Range | Hours | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Apparent Oral Clearance (CL/F) of DTG in Plasma in Part 1 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters per hour | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Apparent Volume of Distribution (Vz/F) of DTG in Part 1 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Observed Concentration at 24 Hours Postdose (C24) of DTG in Plasma in Part 1 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per millilter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Last Observed Quantifiable Concentration (Ct) of DTG in Plasma in Part 1 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Terminal Elimination Phase Half-life (t½) of DTG in Plasma in Part 1 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Lag Time for Absorption (Tlag) of DTG in Part 1 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Median | Full Range | Hours | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | AUC(0-24) of ABC in Plasma in Part 1 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Tmax of ABC in Plasma in Part 1 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Median | Full Range | Hours | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Tlast of ABC in Part 1 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Median | Full Range | Hours | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | CL/F of ABC in Plasma in Part 1 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters per hour | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Vz/F of ABC in Part 1 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | C24 of ABC in Plasma in Part 1 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per millilter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Ct of ABC in Plasma in Part 1 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | T½ of ABC in Plasma in Part 1 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | AUC(0-24) of 3TC in Plasma in Part 1 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Tmax of 3TC in Part 1 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Median | Full Range | Hours | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Tlast of 3TC in Plasma in Part 1 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Median | Full Range | Hours | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | CL/F of 3TC in Plasma in Part 1 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters per hour | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Vz/F of 3TC in Plasma in Part 1 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | C24 of 3TC in Plasma in Part 1 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per millilter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Ct of 3TC in Plasma in Part 1 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | T½ of 3TC in Plasma in Part 1 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | AUC (0-24) of DTG in Plasma in Part 2 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | Tmax of DTG in Plasma in Part 2 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Median | Full Range | Hours | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | Tlast of DTG in Plasma in Part 2 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Median | Full Range | Hours | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | CL/F of DTG in Plasma in Part 2 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters per hour | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | Vz/F of DTG in Plasma in Part 2 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | C24 of DTG in Plasma in Part 2 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per millilter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | Ct of DTG in Plasma in Part 2 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | T½ of DTG in Plasma in Part 2 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | Tlag of DTG in Plasma in Part 2 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Median | Full Range | Hours | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | AUC (0-24) of 3TC in Plasma in Part 2 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | Tmax of 3TC in Plasma in Part 2 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Median | Full Range | Hours | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | Tlast of 3TC in Plasma in Part 2 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Median | Full Range | Hours | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | CL/F of 3TC in Plasma in Part 2 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | PK population. Only those participants with data available at the specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters per hour | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | Vz/F of 3TC in Plasma in Part 2 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | C24 of 3TC in Plasma in Part 2 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per millilter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | Ct of 3TC in Plasma in Part 2 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | T½ of 3TC in Plasma in Part 2 | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) in Part 1 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety population comprised of all participants enrolled in the study, who took at least one dose of study treatment. | | Posted | | Count of Participants | | Participants | | Up to Day 33 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|
| Secondary | Number of Participants With AEs and Serious Adverse Events SAEs in Part 2 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. | | Posted | | Count of Participants | | Participants | | Up to Day 33 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
|
| Secondary | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Blood samples were collected for the analysis of clinical chemistry parameters which included glucose, calcium, potassium, sodium and urea. All participants population included all participants who received at least one dose of study medication. This population corresponded to all participants enrolled. | All Participants Population. | Posted | | Mean | Standard Deviation | Millimoles per liter | | Day 2 of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotranferase (AST) and Creatinine Phosphokinase (CPK) | Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK. | All Participants Population. | Posted | | Mean | Standard Deviation | International units per Liter | | Day 2 of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein | Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein. | All Participants Population. | Posted | | Mean | Standard Deviation | Grams per liter | | Day 2 of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin | Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. | All Participants Population. | Posted | | Mean | Standard Deviation | Micromoles per liter | | Day 2 of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Blood samples were collected for the analysis of clinical chemistry parameters including glucose, calcium, potassium, sodium and urea. | All Participants Population. | Posted | | Mean | Standard Deviation | Millimoles per liter | | Day 2 of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK. | All Participants Population. | Posted | | Mean | Standard Deviation | International units per liter | | Day 2 of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Albumin and Protein | Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein. | All Participants Population. | Posted | | Mean | Standard Deviation | Grams per liter | | Day 2 of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin | Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. | All Participants Population. | Posted | | Mean | Standard Deviation | Micromoles per liter | | Day 2 of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Blood samples were collected for the analysis of clinical chemistry parameters including glucose, calcium, potassium, sodium and urea. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. | All Participants Population. | Posted | | Mean | Standard Deviation | Millimoles per liter | | Baseline (Day -1) and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: ALT, ALP, AST and CPK | Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. | All Participants Population. | Posted | | Mean | Standard Deviation | International units per Liter | | Baseline (Day -1) and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein | Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. | All Participants Population. | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline (Day -1) and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin | Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. | All Participants Population. | Posted | | Mean | Standard Deviation | Micromoles per liter | | Baseline (Day -1) and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Blood samples were collected for the analysis of clinical chemistry parameters including glucose, calcium, potassium, sodium and urea. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. | All Participants Population. | Posted | | Mean | Standard Deviation | Millimoles per liter | | Baseline (Day -1) and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. | All Participants Population. | Posted | | Mean | Standard Deviation | International units per liter | | Baseline (Day -1) and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Albumin and Protein | Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. | All Participants Population. | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline (Day -1) and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin | Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. | All Participants Population. | Posted | | Mean | Standard Deviation | Micromoles per liter | | Baseline (Day -1) and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 1 at indicated time points. | All Participants Population. | Posted | | Mean | Standard Deviation | 10^9 cells per liter | | Day 2 of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1 | Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 1 at indicated time points. | All Participants Population. | Posted | | Mean | Standard Deviation | Picograms | | Day 2 of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1 | Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 1 at indicated time points. | All Participants Population. | Posted | | Mean | Standard Deviation | Femtoliter | | Day 2 of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Absolute Values for Erythrocytes in Part 1 | Blood samples were collected for the analysis erythrocytes in Part 1 at indicated time points. | All Participants Population. | Posted | | Mean | Standard Deviation | 10^12 cells per liter | | Day 2 of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Absolute Values for Hemocrit in Part 1 | Blood samples were collected for the analysis hemocrit in Part 1 at indicated time points. | All Participants Population. | Posted | | Mean | Standard Deviation | Percentage of red blood cells in blood | | Day 2 of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Absolute Values for Hemoglobin in Part 1 | Blood samples were collected for the analysis hemoglobin in Part 1 at indicated time points. | All Participants Population. | Posted | | Mean | Standard Deviation | Grams per liter | | Day 2 of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 2 at indicated time points. | All Participants Population. | Posted | | Mean | Standard Deviation | 10^9 cells per liter | | Day 2 of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 2 | Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points. | All Participants Population. | Posted | | Mean | Standard Deviation | Picograms | | Day 2 of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | Absolute Values for Erythrocyte Mean Corpuscular Volume in Part 2 | Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points. | All Participants Population. | Posted | | Mean | Standard Deviation | Femtoliter | | Day 2 of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | Absolute Values for Erythrocytes in Part 2 | Blood samples were collected for the analysis erythrocytes in Part 2 at indicated time points. | All Participants Population. | Posted | | Mean | Standard Deviation | 10^12 cells per liter | | Day 2 of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | Absolute Values for Hemocrit in Part 2 | Blood samples were collected for the analysis hemocrit in Part 2 at indicated time points. | All Participants Population. | Posted | | Mean | Standard Deviation | Percentage of red blood cells in blood | | Day 2 of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | Absolute Values for Hemoglobin in Part 2 | Blood samples were collected for the analysis hemoglobin in Part 2 at indicated time points. | All Participants Population. | Posted | | Mean | Standard Deviation | Grams per liter | | Day 2 of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value. | All Participants Population. | Posted | | Mean | Standard Deviation | 10^9 cells per liter | | Baseline (Day -1) and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
|
| Secondary | Change From Baseline Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1 | Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value. | All Participants Population. | Posted | | Mean | Standard Deviation | Picograms | | Baseline (Day -1) and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Change From Baseline Values for Erythrocyte Mean Corpuscular Volume in Part 1 | Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value. | All Participants Population. | Posted | | Mean | Standard Deviation | Femtoliter | | Baseline (Day -1) and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Change From Baseline Values for Erythrocytes in Part 1 | Blood samples were collected for the analysis erythrocytes in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value. | All Participants Population. | Posted | | Mean | Standard Deviation | 10^12 cells per liter | | Baseline (Day -1) and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
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| Secondary | Change From Baseline Values for Hemocrit in Part 1 | Blood samples were collected for the analysis hemocrit in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value. | All Participants Population. | Posted | | Mean | Standard Deviation | Percentage of red blood cells in blood | | Baseline (Day -1) and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
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| Secondary | Change From Baseline Values for Hemoglobin in Part 1 | Blood samples were collected for the analysis hemoglobin in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value. | All Participants Population. | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline (Day -1) and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
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| Secondary | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value. | All Participants Population. | Posted | | Mean | Standard Deviation | 10^9 cells per liter | | Baseline (Day -1) and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
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| Secondary | Change From Baseline Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 2 | Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value. | All Participants Population. | Posted | | Mean | Standard Deviation | Picograms | | Baseline (Day -1) and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
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| Secondary | Change From Baseline Values for Erythrocyte Mean Corpuscular Volume in Part 2 | Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value. | All Participants Population. | Posted | | Mean | Standard Deviation | Femtoliter | | Baseline (Day -1) and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
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| Secondary | Change From Baseline Values for Erythrocytes in Part 2 | Blood samples were collected for the analysis erythrocytes in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value. | All Participants Population. | Posted | | Mean | Standard Deviation | 10^12 cells per liter | | Baseline (Day -1) and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
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| Secondary | Change From Baseline Values for Hemocrit in Part 2 | Blood samples were collected for the analysis hemocrit in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value. | All Participants Population. | Posted | | Mean | Standard Deviation | Percentage of red blood cells in blood | | Baseline (Day -1) and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
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| Secondary | Change From Baseline Values for Hemoglobin in Part 2 | Blood samples were collected for the analysis hemoglobin in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value. | All Participants Population. | Posted | | Mean | Standard Deviation | Gram per liter | | Baseline (Day -1) and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
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| Secondary | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as increased, decreased, increase to trace, 1+ and 3+ indicating proportional concentrations in the urine sample. Only participants with abnormal findings for urinalysis at any visit has been presented. | All Participants Population. | Posted | | Count of Participants | | Participants | | Up to Day 33 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
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| Secondary | Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 | Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). | All Participants Population. | Posted | | Count of Participants | | Participants | | Up to Day 33 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
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| Secondary | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as increased, decreased, increase to trace, 1+ and 3+ indicating proportional concentrations in the urine sample. Only participants with abnormal findings for urinalysis at any visit has been presented. | All Participants Population. | Posted | | Count of Participants | | Participants | | Up to Day 33 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
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| Secondary | Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 | Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). | All Participants Population. | Posted | | Count of Participants | | Participants | | Up to Day 33 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
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| Secondary | Number of Participants With Abnormal Electrocardiogram (ECG) Findings in Part 1 | Full 12-lead ECGs were recorded with the participant in a supine position. Absolute QTc Interval: >450, absolute PR Interval: <110 and Absolute QRS Interval: <75 were considered to be potential clinically significant ECG finding. The number of participants with abnormal clinically significant ECG findings are presented. | All Participants Population. | Posted | | Count of Participants | | Participants | | Baseline (Day -1) | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
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| Secondary | Number of Participants With Abnormal ECG Findings in Part 2 | Full 12-lead ECGs were recorded with the participant in a supine position. Absolute QTc Interval: >450, absolute PR Interval: <110 and Absolute QRS Interval: <75 were considered to be potential clinically significant ECG finding. The number of participants with abnormal clinically significant ECG findings are presented | All Participants Population. | Posted | | Count of Participants | | Participants | | Baseline (Day -1) | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
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| Secondary | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Part 1 | Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest. | All Participants Population. | Posted | | Mean | Standard Deviation | Millimeters of mercury | | Day 1 at 4 hours post intervention and Day 2 of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
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| Secondary | Absolute Values for Pulse Rate in Part 1 | Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. | All Participants Population. | Posted | | Mean | Standard Deviation | Beats per minute | | Day 1 at 4 hours post intervention and Day 2 of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
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| Secondary | Absolute Values for Temperature in Part 1 | Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest. | All Participants Population. | Posted | | Mean | Standard Deviation | Degree celsius | | Day 1 at 4 hours post intervention dose and Day 2 of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
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| Secondary | Absolute Values for SBP and DBP of Part 2 | Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest. | All Participants Population. | Posted | | Mean | Standard Deviation | Millimeters of mercury | | Day 1 at 4 hours post intervention dose and Day 2 of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
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| Secondary | Absolute Values for Pulse Rate in Part 2 | Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. | All Participants Population. | Posted | | Mean | Standard Deviation | Beats per minute | | Day 1 at 4 hours post intervention dose and Day 2 of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
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| Secondary | Absolute Values for Temperature in Part 2 | Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest. | All Participants Population. | Posted | | Mean | Standard Deviation | Degree celsius | | Day 1 at 4 hours post intervention dose and Day 2 of each treatment period | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
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| Secondary | Change From Baseline in SBP and DBP of Part 1 | Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. | All Participants Population. | Posted | | Mean | Standard Deviation | Millimeters of mercury | | Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
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| Secondary | Change From Baseline in Pulse Rate of Part 1 | Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. | All Participants Population. | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Change From Baseline in Temperature of Part 1 | Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. | All Participants Population. | Posted | | Mean | Standard Deviation | Degree celsius | | Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Participants received adult TRIUMEQ as 1 conventional tablet administered as direct-to-mouth. | | OG001 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as dispersion and taken immediately. | | OG002 | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received pediatric TRIUMEQ as 10 dispersible tablets administered as direct-to-mouth. |
| |
| Secondary | Change From Baseline in SBP and DBP of Part 2 | Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. | All Participants Population. | Posted | | Mean | Standard Deviation | Millimeters of mercury | | Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | Change From Baseline in Pulse Rate in Part 2 | Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. | All Participants Population. | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
| |
| Secondary | Change From Baseline in Temperature in Part 2 | Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. | All Participants Population. | Posted | | Mean | Standard Deviation | Degree celsius | | Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 50 mg/3TC 300 mg Tablet | Participants received adult DTG and 3TC as one conventional tablet direct-to-mouth | | OG001 | DTG 5 mg/3TC 30 mg Dispersible Tablet | Participants received 10 dispersible pediatric DTG/3TC tablets as dispersion | | OG002 | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Participants received 10 dispersible pediatric DTG/3TC tablets direct-to-mouth |
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