Comparative Bioavailability Study of Clarithromycin 250 mg Tablets
Status:
Completed
Trial end date:
2004-06-01
Target enrollment:
Participant gender:
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.