NCT00778141

Bioequivalence Study of Metformin HCl 750 mg XR Tablets Under Non Fasting Conditions

A Relative Bioavailability Study of Metformin HCl 750 mg XR Tablets Under Non-Fasting Conditions.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (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 non-fasting conditions.

Detailed description

1. Design: Single dose, randomized, two-period, two-treatment, two- sequence crossover study under non-fasting conditions comparing equal doses of the test and reference products. 2. Interval between dosing periods: At least one week 3. Period of confinement: From at least 10.5 hours before dosing until after the 36 hour blood collection each period. Subjects will return to the clinic for subsequent blood collations. A total of thirty six (36) subjects were enrolled in this study; 33 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: 2004-06-01
• First posted: 2008-10-23
• Last updated: 2008-10-23

Locations

1 site across 1 country: United States