Comparative Bioavailability Study of Baclofen 20 mg Tablets in Healthy Male Volunteers / Fasting State
Status:
Completed
Trial end date:
2003-11-01
Target enrollment:
Participant gender:
Summary
The objective of this study was to investigate the bioequivalence of Genpharm's baclofen
tablets following a single, oral 20 mg (1 x 20 mg) dose compared to the Baclofen USP (Watson
Laboratories Inc., USA) administered under fasting conditions. Twenty-seven (27) 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 baclofen 20 mg tablets are
bioequivalent to Baclofen USP 20 mg tablets (Watson Laboratories Inc., USA) administered
under fasting conditions.