Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122)

Merck Sharp & Dohme LLC28 enrolled

Overview

This study will test the hypothesis that the Final Market Image (FMI) sitagliptin/metformin 50 mg/500 mg and 50 mg/850 mg (Fixed Dose Combination) FDC tablet and co-administration of corresponding doses of sitagliptin and China-sourced metformin as individual tablets will be bioequivalent based on assessment of the AUC(0-t) and Cmax, for both sitagliptin and metformin.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes

Interventions

Co-administration of 50 mg sitagliptin and 500 mg metforminDRUG

Co-administration of 50 mg sitagliptin and 500 mg China-sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met500) after fasting for at least 10 hours.

sitagliptin/metformin 50 mg/500 mg tabletDRUG

Single dose administration of the final marketing image (FMI) sitagliptin/metformin 50 mg/500 mg fixed-dose combination (FDC) tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.

Co-administration of 50 mg sitagliptin and 850 mg metforminDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is of Chinese descent * Subject is in good health * Subject is a non-smoker Exclusion Criteria: * Subject has a history of stroke or chronic seizures * Subject has a history of cancer * Subject has had major surgery, donated blood or participated in another investigational study within the past 4 weeks

Outcomes

Primary Outcomes

Area Under the Curve (AUC(0-t)) for Sitagliptin

AUC (0-t) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.

Time frame: baseline through 72 hours postdose

Cmax for Sitagliptin and Metformin

Cmax is the peak serum concentration of a therapeutic drug after administration; and is used to determine the rate and extent of drug absorption. Cmax is reported for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.

Time frame: baseline through 72 hours postdose

Data from ClinicalTrials.gov

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