NCT00865839

A Relative Bioavailability Study of Metformin HCl 500 mg ER Tablets Under Fasting Conditions

A Relative Bioavailability Study of 500 mg Metformin Hydrochloride Extended Release Tablets Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the relative bioavailability of 500 mg Metformin Hydrochloride Extended Release Tablets by Purepac Pharmaceutical Co. with that of 500 mg CLUCOPHAGE® XR Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 500 mg extended-release tablet) in healthy adult volunteers under fasting conditions.

Detailed description

Study Type: Interventional Study Design: Randomized, single dose, two-way crossover study under fasting conditions Official Title: A Relative Bioavailability Study of 500 mg Metformin Hydrochloride Extended Release Tablets Under Fasting Conditions Further study details as provided by Actavis Elizabeth LLC: Primary Outcome Measures: Rate and Extend of Absorption

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Metformin HCl 500 mg tablets, single dose	A: Experimental Subjects received Purepac formulated products under fasting conditions
DRUG	CLUCOPHAGE® XR 500 mg tablets, single dose	B: Active comparator Subjects received Bristol-Myers Squibb Company formulated products under fasting conditions

Timeline

• Start date: 2002-03-01
• Primary completion: 2002-03-01
• Completion: 2002-03-01
• First posted: 2009-03-19
• Last updated: 2010-08-17

Locations

1 site across 1 country: United States