NCT00778427

Bioequivalence Study of Metformin Hydrochloride 1000mg Tablets Under Fasting Conditions

A Study to Compare the Relative Bioavailability of Ranbaxy and Bristol Myers Squibb Formulations of Metformin 1000 mg Tablets in Healthy Adult Volunteers Under Fasting Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to evaluate the relative bioavailability of the test formulation of metformin hydrochloride 1000 mg tablets with an already marketed reference formulation GLUCOPHAGE® (metformin hydrochloride) 1000 mg tablets (Bristol-Myers Squibb Company) under fasted conditions in healthy, male and female adult subjects.

Detailed description

This randomized, single-dose, two-way, crossover study was conducted to compare the relative bioavailability of two formulations of 1000 mg metformin hydrochloride tablets under fasting conditions. The study was conducted with 32 (30 completing) healthy adults in accordance with Protocol No. 10640302 (Revision 0). In each study period, a single dose (1 x 1000 mg tablet) was administered to all subjects following an overnight fast of at least 10 hours. The test formulation was Ohm Laboratories, Inc's (A Group of Ranbaxy Pharmaceuticals Inc.) Metformin Hydrochloride 1000 mg Tablets and the reference formulation was GLUCOPHAGE® (metformin hydrochloride) 1000 mg Tablets (Bristol-Myers Squibb Company). The subjects received the test product in one study period and the reference product in the other period; the order of administration was according to the dosing randomization schedule. There was a 7-day interval between treatments. Blood samples were collected pre-dose and at intervals over 24 hours after each dose. The plasma samples for all subjects completing both periods of the study were sent to Helen Fassoulas, Director of Operations, Warnex Bioanalytical Services Inc., 3885 boul Industriel, Laval, Quebec, H7L4S3 Canada, Telephone: [phone], Fax: [phone] for determination of metformin concentrations. Statistical analysis was performed by Braulio Suarez, M.D., Novum Pharmaceutical Research Services, Wilcrest Green Office Park, 3320 Walnut Bend Lane, Houston, Texas 77042-4712, USA, Telephone: [phone], Fax: [phone]. A total of 32 healthy adult subjects (30 completing).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	metformin hydrochloride 1000 mg tablets

Timeline

• Start date: 2006-02-01
• Primary completion: 2006-02-01
• Completion: 2006-04-01
• First posted: 2008-10-23
• Last updated: 2008-10-23

Locations

1 site across 1 country: United States