Study: Bioequivalence of Proscar Tablets (Finasteride 5 mg) to Procare Tablets

The study evaluated the bioequivalence of two finasteride tablets, Proscar and Procare, in accordance with KFDA guidelines. It involved 26 healthy male subjects in a randomized 2x2 cross-over design. The dissolution profiles of both formulations were similar across various media, and pharmacokinetic parameters such as AUC_t, C_max, and T_max showed minor differences between the two, with no significant sequence effects. The 90% confidence intervals for AUC_t and C_max were within the acceptable range, confirming that Procare is bioequivalent to Proscar.