NCT00865436

A Relative Bioavailability Study of Glyburide/Metformin HCl 5 mg/500 mg Tablets Under Fasting Conditions

A Relative Bioavailability Study of 5 mg Glyburide/500 mg Metformin HCl Tablets Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is compare the relative bioavailability of 5 mg Glyburide/500 mg Metformin Hydrochloride Tablets by Alpharma with that of 5 mg/500 mg CLUCOVANCE® Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 5 mg/500 mg tablet) in healthy adult volunteers administered 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 5 mg Glyburide/500 mg Metformin HCl 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	Glyburide and Metformin Hydrochloride Tablets 5 mg/500 mg	A: Experimental Subjects received Alpharma formulated products under fasting conditions
DRUG	CLUCOVANCE® 5 mg/500 mg Tablets, single dose	B: Active comparator Subjects received Bristol-Myers Squibb Company formulated products under fasting conditions

Timeline

• Start date: 2004-04-01
• Primary completion: 2004-04-01
• Completion: 2004-04-01
• First posted: 2009-03-19
• Last updated: 2010-08-17

Locations

1 site across 1 country: United States