Bioequivalence of finasteride tablet in healthy volunteers by LC-MS/MS

OBJECTIVE To study the pharmacokinetics and bioequivalence of finasteride tablets in 24 healthy male volunteers by LC-MS/MS assay.METHODS A single oral dose 1 mg of test tablets and reference tablets were given to each volunteers according to an open randomized crossover design.The concentration of finasteride in plasma was determined by LC-MS/MS.The pharmacokinetic parameters were calculated and the bioequivalence was compared.RESULTS The main pharmacokinetic parameters of the test and reference preparations were as follows:AUC0-36 were(50.317±22.478) and(48.586±22.345)μg.h.L-1;AUC0-∞ were(52.939±24.352) and(50.880±23.837)μg.h.L-1;Tmax were(1.77±0.44) and(1.79±0.41) h;Cmax were(7.758±3.314) and(7.852±3.456)μg.L-1;t1/2 were(5.10±1.33) and(4.96±1.25) h.The relative bioavailability was(106.0±20.9)%.The main pharmacokinetic parameters showed no statistically significant difference between 2 preparations.CONCLUSION The 2 preparations were bioequivalent.