Bioequivalence of finasteride tablets in healthy volunteers

OBJECTIVE To study the phamacokinetics and relative bioavailability, and to evaluate the bioequivalence of finestaride tablets. METHODS 21 male subjects were involved in a two-way crossover trial design, plasma concentrations were determined by HPLC method following a single oral dose of 20 mg finasteride preparation.RESULTS The pharmacokinetic parameters of the test tablets and the reference tablets in plasma were as follows, AUC0-tn (1 413.9±614.9) and (1 450.4±684.5)μg·h·L-1 ,AUC0-∞(1 460.3 ±641.7) and (1 499.9±711.6)μg·h·L-1,tmax(2.86±0.3) and (2.90±0.3)h,ρmax(216.3±83.4 and (209±83.9)μg·L-1,t1/2(2.34±0.5) and (2.29±0.4)h. CONCLUSION The two kinds of finasteride tablet are of bioequivalence.