NCT00648960

Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fasting State

Single Dose Crossover Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Healthy Male and Female Volunteers / Fasting State

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to investigate the bioequivalence of Genpharm's clarithromycin tablets following a single, oral 500 mg (1 x 500 mg) dose compared to the Biaxin® filmtab® (Abbott Laboratories USA) administered under fasting conditions. Sixty-four (64) 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 clarithromycin 500 mg tablets are bioequivalent to Biaxin® filmtab® 500 mg tablets (Abbott Laboratories USA) administered under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Clarithromycin	Single-dose 500 mg immediate-release oral tablet
DRUG	Clarithromycin	Single-dose 500 mg immediate-release oral dose

Timeline

• Start date: 2003-07-01
• Primary completion: 2003-07-01
• Completion: 2003-07-01
• First posted: 2008-04-01
• Last updated: 2008-04-01

Locations

1 site across 1 country: Canada