NCT00778791

Bioequivalence Study of Metformin HCl 750 mg XR Under Fasting Conditions

The Objective of This Study is to Compare the Relative Bioavailability of Metformin HC1 750 mg Extended-Release Tablets (Ranbaxy) With That of Glucophage® XR 750 mg Tablets (Bristol Myers Squibb) in Healthy, Adult, Subjects Under Fasting Conditions.

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

Summary

The objective of this study is to compare the relative bioavailability of metformin HC1 750 mg extended-release tablets (Ranbaxy) with that of Glucophage® XR 750 mg tablets (Bristol Myers Squibb) in healthy, adult, subjects under fasting conditions.

Detailed description

This study was randomised, two-treatment, two-period, two-sequence, single-dose, crossover bioavailability study planned on 60 healthy, adult, subjects under fasting conditions. 60 subjects were enrolled and 55 subjects completed all the periods of the study. Both periods were separated by a washout period of fourteen days A total of Sixty (60) subjects were enrolled in this study; 55 completed the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	metformin HC1 750 mg extended-release tablets

Timeline

• Start date: 2004-04-01
• Primary completion: 2004-04-01
• Completion: 2004-07-01
• First posted: 2008-10-23
• Last updated: 2008-10-23

Locations

1 site across 1 country: United States