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.