Bioequivalence Study of Metformin Hydrochloride Extended Release 750 mg Tablets Versus Glucophage XR® 750 mg Tablet in Healthy Volunteers Under Fed Conditions.
NCT01089205 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2010-07-29
Summary
Objective:
To study Bioequivalence of Metformin Hydrochloride Extended Release 750 mg Tablets (Test formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 750 mg Tablet (Reference formulation, Bristol-Myers Squibb company, USA) in Healthy volunteers under Fed Conditions.
Study Design:
An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study
Conditions
Interventions
- DRUG
Sponsors & Collaborators
-
Torrent Pharmaceuticals Limited
lead INDUSTRY
Principal Investigators
-
Jogesh mahajan, MBBS · Torrent Pharma Ltd.
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
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