Bioequivalent Assessment of Finasteride Granules in Chinese Healthy Volunteers

Objective:To evaluate the bioequivalence of finasteride granules and tablets.Methods:A single oral dose of finasteride was given respectively to 22 male healthy volunteers in a randomized self-crossover program with double cycle to study its pharmacokinetics.The samples were analyzed by HPLC-MS/MS.The pharmacokinetic parameters and bioequivalence of two preparations were calculated.Results:The linear range of finasteride in plasma was from 1 to 100 μg · L-1(r = 0.998 1) and the limit of detection was 1 μg · L-1,while RSD of intra-day and inter-day were all less than 15%.The main pharmacokinetic parameters of finasteride granules and finasteride tablets were as follows:Cma(x39.36±6.18) and(43.86±11.95) μg · L-1;tmax(2.02±0.70) and(1.82±0.85) h;t1/(27.35±3.80) and(6.67±2.75) h;AUC0-∞(398.92±170.92) and(389.41±160.55) μg · h · L-1;AUC0(-t367.84±137.08) and(367.65 ± 155.40) μg · h · L-1;F0-t and F0-∞ of test preparation were(105.17±29.84)% and(106.35±29.48)%.Conclusion:The f inasteride granules is bioequivalent to finasteride tablets.