Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fed State
Status:
Completed
Trial end date:
2003-03-01
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 fed conditions. Forty-four (44)
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 fed conditions.