Bioequivalence Study of Metformin Hydrochloride Extended Release 750 mg Tablets Versus Glucophage XR® 750 mg Tablet in Healthy Volunteers Under Fed Conditions.
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|ClinicalTrials.gov Identifier: NCT01089205|
Recruitment Status : Completed
First Posted : March 18, 2010
Last Update Posted : July 29, 2010
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.
An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: Metformin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study 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.|
|Experimental: Torrent's Metformin tablets 750 mg||Drug: Metformin|
|Active Comparator: Glucophage XR® of Bristol- Myers Squibb Company, USA||Drug: Metformin|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01089205
|Principal Investigator:||Jogesh mahajan, MBBS||Torrent Pharma Ltd.|