Bioequivalence of two kinds of finasterides tablets in healthy volunteers

AIM: To study the phamacokinetic and relative bioavailability and evaluate the bioequivalence of two kinds of finestarid tablets. METHODS: A random crossover trial was designed. Plasma concentrations were determined by HPLC method following a single oral dose 40 mg two different brand finasteride preparations. RESULTS: The pharmacokinetic parameters of the test tablets and the reference tablets in plasma were as following: AUC_ 0-24 were(1597±s 610) μg·h·L -1 and (1569±629) μg·h·L -1,AUC_ 0-∞ were(1680±607) μg·h·L -1 and(1675±628)μg·h·L -1,T_ max were( 2.4 ±0.3) h and( 2.3± 0.3) h,C_ max were (280±112) μg·L -1 and (284±110) μg·L -1, T_ 1/2 were( 2.9± 0.8) h and( 3.3± 1.0) h. When Proscar was reference preparation, the F_ 0-24 of finasteride was(103±18) %, and the F_ 0-∞ was(101±16) %. CONCLUSION: The two kinds of finasteride tablets are of bioequivalence.