NCT00648830

Comparative Bioavailability Study of Clarithromycin 250 mg Tablets

Randomized Single Dose Crossover Replicate Comparative Bioavailability Study of Clarithromycin 250 mg Tablets in Healthy Male and Female Volunteers Under Fasted Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (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 clarithromycin tablets following a single, oral 250 mg (1 x 250 mg) dose compared to the Biaxin® filmtab® (Abbott Laboratories USA) administered under fasted conditions. Thirty-four (34) healthy, light-, non- or ex-smoking subjects of at least 18 a years of age were randomized, in this four-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 clarithromycin 250 mg tablets are bioequivalent to Biaxin® filmtab® 250 mg tablets (Abbott Laboratories USA) administered under fasted conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
PROCEDURE	Clarithromycin	Single-dose of Clarithromycin 250 mg oral immediate-release tablets
DRUG	Clarithromycin	single-dose 250 mg immediate-release oral tablets

Timeline

• Start date: 2004-05-01
• Primary completion: 2004-06-01
• Completion: 2004-06-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: Canada