Bioequivalence of a single 10-mg dose of finasteride 5-mg oral disintegrating tablets and standard tablets in healthy adult male Han Chinese volunteers: a randomized sequence, open-label, two-way crossover study

Clinical Therapeutics
Li ChenQin Zou

Abstract

Finasteride, an inhibitor of the steroid 5alpha-reductase, has been approved for the treatment of benign prostatic hyperplasia and androgenetic alopecia. An orally disintegrating tablet (ODT) 5-mg formulation of finasteride was recently developed. Information regarding its pharmacokinetics and bioequivalence was required to assess the efficacy and safety of this formulation before marketing it in China. The aims of this study were to compare the bioavailability of finasteride ODTs and standard tablets in healthy adult male Han Chinese volunteers and to determine whether any observed differences exceeded Chinese regulatory guidelines for bioequivalence. This single-dose, randomized, open-label, 2-way crossover trial was conducted in China. Healthy adult male Han Chinese volunteers were enrolled. Participants were randomly assigned to receive 10 mg of either the ODT or standard tablet formulation, followed by a 1-week washout period and administration of the alternate formulation. Doses were administered after a 12-hour overnight fast. For analysis of pharmacokinetic properties, including C(max), AUC(0-24), and AUC(0-infinity), blood samples were obtained at 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 8, 11, 14, and 24 hours after administr...Continue Reading

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