Bioequivalence Study Between SKF101804 Cefixime 200 Milli... | NCT03408392

NCT03408392

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test followed by Reference Formulation	Experimental	Subjects will be randomized to receive single dose of Test formulation (SKF101804: cefixime 200 mg/ 5 mL) on Day 1 of the treatment period 1 and Reference formulation (cefixime 200 mg/5 mL) on Day 1 of the treatment period 2. There will be wash out period of 7-14 days between the two treatment periods.	Drug: Test formulation A Drug: Reference formulation B
Reference followed by Test Formulation	Experimental	Subjects will be randomized to receive single dose of Reference formulation (cefixime 200 mg/5 mL) on Day 1 of the treatment period 1 and Test formulation (SKF101804: cefixime 200 mg/ 5 mL) on Day 1 of the treatment period 2. There will be wash out period of 7-14 days between the two treatment periods.	Drug: Test formulation A Drug: Reference formulation B

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Test formulation A	Drug	Test formulation: SKF101804 will be available as oral suspension supplied as powder for reconstitution (Off-white to cream coloured powder). Subjects will receive single dose of 5 mL of suspension thus receiving 200 mg dose of cefixime. The suspension is a white to off white viscous suspension with a fruit flavor and odor.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC [0-t]) for Cefixime	Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods. Pharmacokinetic Population comprised of participants who completed the study and for whom primary pharmacokinetic parameters could be calculated for all treatment periods were included in the statistical pharmacokinetic analysis of the study.	Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period
Maximum Observed Plasma Concentration (Cmax) Within a Participant Across All Treatments of Cefixime	Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.	Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period

Secondary Outcomes

Measure	Description	Time Frame
Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to (AUC [0-infinity]) Across All Treatments for Cefixime	Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
Subject must be healthy, non-smoker, as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the normal reference range for the population being studied may be included at investigator discretion in consultation with the Medical Monitor if required, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Subject with a body weight 50 kilogram (kg) and body mass index (BMI) within the range 19-30 kilogram per meter square (kg/m^2) (inclusive).
A healthy male subject must agree to use contraception during the treatment period and for at least 5 days after the last dose of study treatment and refrain from donating sperm during this period.
A female subject is eligible to participate if she is not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 30 days after the last dose of study treatment.
A subject should be capable of giving signed informed consent.

Exclusion Criteria:

Subject with history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.
Subjects with any other condition that is capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.
Subject with abnormal renal function, as determined by creatinine clearance and considered as clinically significant by the investigator will be excluded.
Subject with abnormal blood pressure (BP) as determined by the investigator.
Subject with lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
Subject who had breast cancer within the past 10 years.
ALT >1.5 times upper limit of normal (ULN).
Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Subject with current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Subject with history of colitis
Subject with history of cephalosporin induced hemolytic anemia.
QT interval corrected for heart rate according to Bazett's formula (QTcB) >450 milliseconds (msec). Subjects with a known risk of QT prolongation will be excluded.
Past or intended use of over-the-counter or prescription medication including herbal medications, within 14 days prior to dosing unless in the opinion of the investigator and sponsor, the medication will not interfere with the study.
Participation in the study would result in loss of blood or blood products in excess of 500 mL within 90 days.
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Current enrolment or past participation within the last 90 days before signing of consent in this or any other clinical study involving an investigational study treatment or any other type of medical research.
Presence of Hepatitis B surface antigen (HBsAg) at screening. Positive Hepatitis C antibody test result at screening. Subjects with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C ribonucleic acid (RNA) test is obtained.
Positive pre-study drug/alcohol screen.
Positive human immunodeficiency virus (HIV) antibody test.
Regular use of known drugs of abuse.
Subjects with regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 gram (g) of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
Subjects with urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
Subjects who are sensitive to heparin or heparin-induced thrombocytopenia.
Subjects with known sensitivity to any drugs from the class of cephalosporin, or components thereof.
Subjects with known sensitivity to any drugs from the class of penicillin, or components thereof.
Subjects with known sensitivity to any of the study treatments, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Bloemfontein	Free State	9300	South Africa

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	SKF101804 Cefixime Followed by Cefixime Reference Formulation	Eligible participants received single dose of Test formulation (SKF101804 cefixime 200 mg /5 mL suspension) orally on Day 1 in Treatment period 1. It was followed by a washout period of at least 7 days and not more than 14 days. Participants received single dose of Reference formulation (cefixime 200 mg/5 mL suspension) orally on Day 1 in Treatment period 2.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Nov 13, 2017

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

FG00014 subjects
FG00114 subjects

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	All Participants	Eligible participants received a single dose of Test formulation (SKF101804 cefixime 200 mg /5 mL suspension) followed by Reference formulation (cefixime 200 mg/5 mL suspension) or vice versa, administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants	BG00028

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00028.9± 7.90

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0007
Male	BG00021

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Mixed Race	BG0003
White/Caucasian/European Heritage	BG0004

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC [0-t]) for Cefixime

Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods. Pharmacokinetic Population comprised of participants who completed the study and for whom primary pharmacokinetic parameters could be calculated for all treatment periods were included in the statistical pharmacokinetic analysis of the study.

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Hour*nanogram per milliliter

Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period

ID	Title	Description
OG000	SKF101804 Cefixime	Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Cefixime Reference Formulation	Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants	OG00028 OG00128

Title

Denominators

Categories

Title	Measurements
	OG00020000± 32.9 OG00119000± 34.3

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Percentage ratio	105.38			2-Sided	90	96.11	115.54					Equivalence	Bio-equivalence analysis comparing cefixime test and reference product has been presented.

Primary

Maximum Observed Plasma Concentration (Cmax) Within a Participant Across All Treatments of Cefixime

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Nanogram per milliliter

Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period

ID	Title	Description
OG000	SKF101804 Cefixime	Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Cefixime Reference Formulation	Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Secondary

Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to (AUC [0-infinity]) Across All Treatments for Cefixime

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Hour*nanogram per milliliter

Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period

ID	Title	Description
OG000	SKF101804 Cefixime	Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Cefixime Reference Formulation	Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Secondary

Time of Occurrence of Cmax (Tmax) for Cefixime

Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods. Tmax of cefixime was analyzed using a nonparametric test to compute point estimate of the median and full range.

Pharmacokinetic Population

Posted

Median

Full Range

Hours

Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period

ID	Title	Description
OG000	SKF101804 Cefixime	Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Cefixime Reference Formulation	Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Secondary

Percentage of AUC(0-infinity) Obtained by Extrapolation (%AUCex) for Cefixime

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Percentage of AUCex

Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period

ID	Title	Description
OG000	SKF101804 Cefixime	Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Cefixime Reference Formulation	Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Secondary

Terminal Phase Half-life (T1/2) for Cefixime

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours

Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period

ID	Title	Description
OG000	SKF101804 Cefixime	Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Cefixime Reference Formulation	Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Secondary

Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE)

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. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect or other situations. The analysis was performed on Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.

Safety Population

Posted

Count of Participants

Participants

Up to Day 16 in each treatment period

ID	Title	Description
OG000	SKF101804 Cefixime	Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Cefixime Reference Formulation	Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Secondary

Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including ALT, ALP and AST.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Units per liter

Day -1 and Day 2 of each treatment period

ID	Title	Description
OG000	SKF101804 Cefixime	Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Cefixime Reference Formulation	Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Secondary

Blood Urea Nitrogen (BUN) at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of BUN.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Milligrams per deciliter

Day -1 and Day 2 of each treatment period

ID	Title	Description
OG000	SKF101804 Cefixime	Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Cefixime Reference Formulation	Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Secondary

Calcium, Glucose, Potassium and Sodium at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including calcium, glucose, potassium and sodium.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Millimoles per liter

Day -1 and Day 2 of each treatment period

ID	Title	Description
OG000	SKF101804 Cefixime	Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Cefixime Reference Formulation	Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Secondary

Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including total bil, direct bil and creat.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Micromoles per liter

Day -1 and Day 2 of each treatment period

ID	Title	Description
OG000	SKF101804 Cefixime	Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Cefixime Reference Formulation	Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Secondary

Total Protein at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of total Protein.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Grams per liter

Day -1 and Day 2 of each treatment period

ID	Title	Description
OG000	SKF101804 Cefixime	Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Cefixime Reference Formulation	Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Secondary

Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including platelets, neutrophils, monocytes, lymphocytes, leucocyte, eosinophils and basophils.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

10^9 cells per liter

Day -1 and Day 2 of each treatment period

ID	Title	Description
OG000	SKF101804 Cefixime	Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Cefixime Reference Formulation	Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts

Secondary

Mean Corpuscular Volume (MCV) at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCV.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Femtoliter

Day -1 and Day 2 of each treatment period

ID	Title	Description
OG000	SKF101804 Cefixime	Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Cefixime Reference Formulation	Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Secondary

Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCH.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Picogram

Day -1 and Day 2 of each treatment period

ID	Title	Description
OG000	SKF101804 Cefixime	Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Cefixime Reference Formulation	Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Secondary

Erythrocyte Count at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of erythrocyte count.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

10^12 cells per liter

Day -1 and Day 2 of each treatment period

ID	Title	Description
OG000	SKF101804 Cefixime	Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Cefixime Reference Formulation	Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Secondary

Hematocrit at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematocrit.

Safety Population. Only those participants with data available at the specified time points were analyzed

Posted

Mean

Standard Deviation

Proportion of red blood cells in blood

Day -1 and Day 2 of each treatment period

ID	Title	Description
OG000	SKF101804 Cefixime	Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Cefixime Reference Formulation	Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Secondary

Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including MCHC and Hb.

Safety Population. Only those participants with data available at the specified time points were analyzed

Posted

Mean

Standard Deviation

Grams per deciliter

Day -1 and Day 2 of each treatment period

ID	Title	Description
OG000	SKF101804 Cefixime	Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Cefixime Reference Formulation	Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Secondary

Percent Reticulocytes at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of percent reticulocytes.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Percentage of reticulocytes

Day -1 and Day 2 of each treatment period

ID	Title	Description
OG000	SKF101804 Cefixime	Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Cefixime Reference Formulation	Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Secondary

Number of Participants With Potential Clinical Importance (PCI) Abnormal Findings for Urinalysis

Urine samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2. PCI ranges for urinalysis parameters were as follows: specific gravity 1.001 to 1.035 kilogram per liter, blood negative (0 to 9) RBC per microliter, pH 4.6 to 8.0, protein negative (0.0 to 0.14) gram per liter, glucose negative (0 to 5.49) millimoles per liter, ketones negative (0.0 to 0.49) millimoles per liter, urobilinogen (0.0 to 1.0) milligrams per deciliter, urine leucocytes negative (0 to 14) leucocytes per microliter, Urine WBC, RBC and epithelial cells 0 to 5 high power per field.

Safety Population. Only those participants with data available at the specified time points were analyzed

Posted

Count of Participants

Participants

Day -1 and Day 2 of each treatment period

ID	Title	Description
OG000	SKF101804 Cefixime	Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Cefixime Reference Formulation	Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Secondary

Respiratory Rate at Indicated Time-points

Respiratory rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Breaths per minute

Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period

ID	Title	Description
OG000	SKF101804 Cefixime	Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Cefixime Reference Formulation	Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Secondary

Pulse Rate at Indicated Time-points

Pulse rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Beats per minute

Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period

ID	Title	Description
OG000	SKF101804 Cefixime	Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Cefixime Reference Formulation	Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Secondary

Body Temperature at Indicated Time-points

Body temperature of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Degree Celsius

Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period

ID	Title	Description
OG000	SKF101804 Cefixime	Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Cefixime Reference Formulation	Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Secondary

Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points

Blood pressure of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Millimeters of mercury

Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period

ID	Title	Description
OG000	SKF101804 Cefixime	Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Cefixime Reference Formulation	Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	SKF101804 Cefixime	Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.	0	28	0	28	0	28
EG001	Cefixime Reference Formulation	Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.	0	28	0	28	0	28

ID	Term
D001424	Bacterial Infections

Units	Counts
Participants	OG00028 OG00128

Units	Counts
Participants	OG00028 OG00128

Units	Counts
Participants	OG00028 OG00128