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.

摘要: Background: Finasteride, an inhibitor of the steroid 5α-reductase, has been approved for treatment benign prostatic hyperplasia and androgenetic alopecia. An orally disintegrating tablet (ODT) 5-mg formulation finasteride was recently developed. Information regarding its pharmacokinetics bioequivalence required to assess efficacy safety this before marketing it in China. Objectives: The aims study were compare bioavailability ODTs standard tablets healthy adult male Han Chinese volunteers determine whether any observed differences exceeded regulatory guidelines bioequivalence. Methods: This single-dose, randomized, open-label, 2-way crossover trial conducted Healthy enrolled. Participants randomly assigned receive 10 mg either ODT or formulation, followed by a 1-week washout period administration alternate formulation. Doses administered after 12-hour overnight fast. For analysis pharmacokinetic properties, including C max , AUC 0–24 0–∞ blood samples obtained at 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 8, 11, 14, 24 hours administration. formulations be considered bioequivalent if calculations 90% CI ratio means measures test reference fell within limits, 80% 125%, logarithmic (log) transformation AUC, Schuirmann’s two 1-sided tests showed P < 0.05. Tolerability assessed using vital sign measurements (ie, pressure, body temperature, heart rate, respiratory rate), laboratory hematology, biochemistry, hepatic function,