Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fasting State
Status:
Completed
Trial end date:
2003-07-01
Target enrollment:
Participant gender:
Summary
The objective of this study was to investigate the bioequivalence of Genpharm's
clarithromycin tablets following a single, oral 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.