NCT01089179

Bioequivalence Study of Metformin Hydrochloride Extended Release 500 mg Tablet Versus Glucophage XR® 500 mg Tablet in Healthy Volunteers Under Fed Conditions

An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study of Metformin Hydrochloride Extended Release 500 mg Tablet (Test Formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 500 mg Tablet (Reference Formulation, Bristol-Myers Squibb Company, USA) in Healthy Volunteers Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Torrent Pharmaceuticals Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: —

Summary

Objective: An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single- Dose Bioequivalence Study of Metformin Hydrochloride Extended Release 500 mg Tablet (Test formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 500 mg Tablet (Reference formulation, Bristol- Myers Squibb company, USA) in Healthy Volunteers under Fed Conditions. Study Design: An Open-Label, Randomised, 2-Period, 2-Treatment, Crossover Study under fed condition.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Metformin

Timeline

• First posted: 2010-03-18
• Last updated: 2010-05-07

Locations

1 site across 1 country: India