CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 28 enrolled
Drug / intervention
Co-administration of 50 mg sitagliptin and 500 mg metformin +3 moredrug
Likely dose
Co-administration of 50 mg sitagliptin and 500 mg metforminfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01093794
NCT01093794Phase 1Completed
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A Bioequivalence Study With Two Tablet Strengths of the Final Market Image (FMI) Sitagliptin/Metformin Fixed Dose Combination (FDC) Tablet

Merck Sharp & Dohme LLC·interventional·Posted Mar 26, 2010·Updated Jul 28, 2015

In Brief

A Phase 1 clinical trial evaluating Co-administration of 50 mg sitagliptin and 500 mg metformin, sitagliptin/metformin 50 mg/500 mg tablet, and 2 other interventions for Type 2 Diabetes. Completed, enrolled 28 participants.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 26, 2010
Enrollment StartApr 1, 2010
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.3 years ago

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

Co-administration of 50 mg sitagliptin and 850 mg China sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met850) after fasting for at least 10 hours.

sitagliptin/metformin 50 mg/850 mg tabletdrug

Single dose administration of the FMI sitagliptin/metformin 50 mg/850 mg FDC tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.