CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 60 enrolled
Drug / intervention
Glyburide/Metformin 5 mg/500 mg Tablets +1 moredrug
Likely dose
Glyburide/Metformin 5 mg/500 mg Tabletsfrom 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/NCT00835991
NCT00835991Phase 1Completed
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Randomized, 2-Way Crossover, Bioequivalence Study of Glyburide/Metformin 5 mg/500 mg Film-Coated Tablets and Glucovance® 5 mg/500 mg Film-Coated Tablets in Healthy Subjects Under Fed Conditions

Teva Pharmaceuticals USA·interventional·Posted Feb 4, 2009·Updated Aug 19, 2024

In Brief

A Phase 1 clinical trial evaluating Glyburide/Metformin 5 mg/500 mg Tablets and Glucovance® 5 mg/500 mg Tablets for Healthy. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The objective of this study is to compare the rate and extent of absorption of Glyburide/Metformin 5 mg/500 mg film-coated tablets (test) versus Glucovance® (reference) administered as 1 x 5 mg/500 mg film-coated tablet under fed conditions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--

Timeline

Phase 1CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 4, 2009
Enrollment StartFeb 1, 2003
Primary CompletionFeb 1, 2003
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago

Interventions

Glyburide/Metformin 5 mg/500 mg Tabletsdrug

1 x 5 mg/500 mg, single-dose fed

Glucovance® 5 mg/500 mg Tabletsdrug

1 x 5 mg/500 mg, single-dose fed