Pharmacokinetic and bioequivalence evaluation of two abiraterone acetate tablets under fasting conditions in healthy Chinese volunteers.

OBJECTIVES: The combination of abiraterone acetate and prednisone is administered to patients with metastatic castration-resistant prostate cancer who have not responded to docetaxel-based chemotherapy. This study was conducted to assess the bioequivalence between generic and branded 250 mg abiraterone acetate tablets in healthy Chinese participants under fasting conditions. METHOD: A single-dose, randomized, open-label, three-way, three-period, partially replicated crossover trial design was developed. A total of 45 healthy participants were enrolled and randomly assigned to three groups. Each participant received a single oral dose of either the test formulation (generic abiraterone acetate) or the reference formulation (brand-name abiraterone acetate), followed by a 7-day washout period before receiving the alternate formulation in subsequent periods. Blood samples were collected before dosing and up to 72 h post-dose to determine plasma abiraterone concentrations. These data were used to generate concentration-time curves and to calculate key pharmacokinetic parameters. RESULTS: Our results indicated that there were no notable differences between the two formulations in terms of peak plasma concentration (C_max), area under the curve from time zero to the last quantifiable concentration (AUC0-t), and area under the curve from time zero to infinity (AUC0-∞). CONCLUSIONS: Statistical evaluation confirmed that the generic and branded formulations were bioequivalent when administered under fasting conditions.