Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080)

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Sitagliptin phosphate/metformin hydrochloride FDC; Drug: Sitagliptin phosphate; Drug: Metformin hydrochloride

• Registration Number: NCT00929201
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study will demonstrate the bioequivalence of metformin after single dose administration of sitagliptin/metformin 50/500 mg fixed dose combination (FDC) tablet and concomitant administration of single doses of sitagliptin 50 mg and metformin 500 mg as individual tablets after consumption of a high-fat meal.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-03
• Study Completion: 2008-05
• Study First Submitted: 2009-06-25
• Study First Submitted QC: 2009-06-25
• Study First Posted: 2009-06-26
• Results First Submitted: 2010-01-05
• Results First Submitted QC: 2010-01-05
• Results First Posted: 2010-02-01
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-22
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• is in good health
• is a nonsmoker
• is willing to follow all study guidelines

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Exclusion Criteria

• has or has a history of any illness or condition that might confound the results of the study or make participation unsafe for the participant
• is a nursing mother
• is unwilling to consume the required high-fat breakfast

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sita + Met then Sita/Met FDC	Sitagliptin phosphate/metformin hydrochloride FDC	Participants receive sitagliptin (Sita) 50 mg and metformin (Met) 500 mg individual tablets administered concomitantly as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin/metformin (Sita/Met) 50/500 mg FDC tablet administered as a single dose during Period 2.
Sita + Met then Sita/Met FDC	Sitagliptin phosphate	Participants receive sitagliptin (Sita) 50 mg and metformin (Met) 500 mg individual tablets administered concomitantly as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin/metformin (Sita/Met) 50/500 mg FDC tablet administered as a single dose during Period 2.
Sita/Met FDC then Sita + Met	Sitagliptin phosphate/metformin hydrochloride FDC	Participants receive sitagliptin/Metformin 50 mg/500 mg FDC tablet administered as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 2.
Sita/Met FDC then Sita + Met	Sitagliptin phosphate	Participants receive sitagliptin/Metformin 50 mg/500 mg FDC tablet administered as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 2.
Sita/Met FDC then Sita + Met	Metformin hydrochloride	Participants receive sitagliptin/Metformin 50 mg/500 mg FDC tablet administered as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 2.
Sita + Met then Sita/Met FDC	Metformin hydrochloride	Participants receive sitagliptin (Sita) 50 mg and metformin (Met) 500 mg individual tablets administered concomitantly as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin/metformin (Sita/Met) 50/500 mg FDC tablet administered as a single dose during Period 2.

Primary Outcome Measures

Name	Time	Method
Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin	Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose	Serum samples were used to determine the AUC from time 0 to infinity for metformin.

Secondary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax) of Metformin	Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose	Serum samples were used to determine the maximum concentration for metformin.