At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 28 enrolled
Drug / intervention
metformin (Diabex) +3 moredrug
Likely dose
metformin (Diabex) 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.
Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets Manufactured by Bristol-Myers Squibb Relative to 500 mg and 1000 mg Diabex (Metformin) Tablets Marketed in Australia by Alphapharm Administered to Healthy Subjects in the Fed State
In Brief
A Phase 1 clinical trial evaluating metformin (Diabex) and metformin (Glucophage™) for Type 2 Diabetes Mellitus. Completed, enrolled 28 participants across 1 site.
Detailed Summary
To demonstrate the bioequivalence of 500 mg and 1000 mg Glucophage tablets manufactured by BMS relative to the respective strengths of 500 mg and 1000 mg Diabex tablets marketed in Australia by Alphapharm in the fed state
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2010
First PostedFeb 2010
Primary CompletionApr 2010
TodayJul 2026
First PostedFeb 15, 2010
Enrollment StartFeb 1, 2010
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.4 years ago
Interventions
metformin (Diabex)drug
Tablets, Oral, 500 mg, Once daily, single dose
metformin (Glucophage™)drug
Tablets, Oral, 500 mg, Once Daily, single dose
metformin (Glucophage™)drug
Tablets, Oral, 1000 mg, Once daily, single dose
metformin (Diabex)drug
Tablets, Oral, 1000 mg, Once daily, single dose