NCT00647738

Comparative Bioavailability Study of Baclofen 20 mg Tablets in Healthy Male Volunteers / Fasting State

Single Dose Crossover Comparative Bioavailability Study of Baclofen 20 mg Tablets in Healthy Male Volunteers / Fasting State

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to investigate the bioequivalence of Genpharm's baclofen tablets following a single, oral 20 mg (1 x 20 mg) dose compared to the Baclofen USP (Watson Laboratories Inc., USA) administered under fasting conditions. Twenty-seven (27) healthy, light-, non- or ex-smoking subjects of at least 18 a years of age were randomized, in this two-period, two-treatment crossover bioequivalence study conducted by Eric Sicard, M.D. at Algorithme Pharma Inc. Montreal, Canada. Statistical analysis of the data reveals that 90% confidence intervals are within the acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters AUCT, AUCI and Cmax. This study demonstrates that Genpharm's baclofen 20 mg tablets are bioequivalent to Baclofen USP 20 mg tablets (Watson Laboratories Inc., USA) administered under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Baclofen	Single-dose 20 mg immediate-release oral tablets
DRUG	Baclofen	Single-dose 20 mg immediate-release oral tablet

Timeline

• Start date: 2003-10-01
• Primary completion: 2003-11-01
• Completion: 2003-11-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: Canada