At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
Glucophage® XR 750 mg Tablets +1 moredrug
Likely dose
Glucophage® XR 750 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.
A Two-Way Crossover, Open-Label, Single-Dose, Fasting, Bioequivalence Study of Metformin ER 750 mg Tablets Versus Glucophage® XR 750 mg Tablets in Normal Healthy Non-smoking Male and Female Subjects
In Brief
A Phase 1 clinical trial evaluating Glucophage® XR 750 mg Tablets and Metformin ER 750 mg Tablets for Healthy. Completed, enrolled 32 participants across 1 site.
Detailed Summary
The objective of this study is to compare the rate and extent of absorption of metformin from a test formulation of Metformin ER 750 mg Tablets versus the reference Glucophage® XR 750 mg Tablets under fasting conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2003
Primary CompletionAug 2003
First PostedFeb 2009
TodayJul 2026
First PostedFeb 3, 2009
Enrollment StartAug 1, 2003
Primary CompletionAug 1, 2003
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago
Interventions
Glucophage® XR 750 mg Tabletsdrug
1 x 750 mg, single-dose fasting
Metformin ER 750 mg Tabletsdrug
1 x 750 mg, single-dose fasting