Bioequivalence study of generic finasteride in healthy male volunteers.

The study evaluated the bioequivalence of a generic 5-mg finasteride tablet compared to the original product in 12 healthy Thai male volunteers using a randomized two-way crossover design. After administering a single oral dose and collecting blood samples over 30 hours, the pharmacokinetic parameters were analyzed. The maximum concentrations (Cmax) and time to reach Cmax (Tmax) were similar for both the test and reference products. The analysis showed that the ratios of AUC 0-∞ and Cmax for the test/reference were within the bioequivalence range of 0.80-1.25, confirming that the generic and original finasteride products were bioequivalent.