CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 61 enrolled
Drug / intervention
Sitagliptin phosphate/metformin hydrochloride FDC +2 moredrug
Likely dose
Sitagliptin phosphate/metformin hydrochloride FDC 500 mgfrom 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/NCT00929201
NCT00929201Phase 1Completed
CompareCT.gov

An Open-Label, Randomized, Two-Period Crossover Definitive Bioequivalence Study With the Final Marketed Image (FMI) Sitagliptin/Metformin Fixed-Dose Combination (FDC) Tablet and Co-Administration of the Sitagliptin and Metformin Individual Tablets After Consumption of a High-Fat Meal in Healthy Adult Subjects

Merck Sharp & Dohme LLC·interventional·Posted Jun 26, 2009·Updated Aug 13, 2015

In Brief

A Phase 1 clinical trial evaluating Sitagliptin phosphate/metformin hydrochloride FDC, Sitagliptin phosphate, and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 61 participants.

Detailed 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.

Study Details

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

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 26, 2009
Enrollment StartJan 1, 2008
Primary CompletionMar 1, 2008
Study CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.0 years ago

Interventions

Sitagliptin phosphate/metformin hydrochloride FDCdrug

Single dose sitagliptin/metformin 50/500 mg FDC tablet after consumption of a high-fat meal in one of two treatment periods.

Sitagliptin phosphatedrug

Single dose sitagliptin 50 mg tablet after consumption of a high-fat meal in one of two treatment periods.

Metformin hydrochloridedrug

Single dose metformin 500 mg tablet after consumption of a high-fat meal in one of two treatment periods.