Bioequivalence Evaluation of Abiraterone 500 mg Tablets Compared with Reference in Healthy Adult Male Subjects Under Fasting Conditions: A Randomized, Replicated Crossover Study
Dr. Sumanlatha, Clinical Research, Hyderabad
DOI: https://doi.org/10.63712/bpsrj-v2i3p001
ABSTRACT:
Background: Abiraterone acetate is an androgen biosynthesis inhibitor widely used in the management of metastatic hormone-sensitive and castration-resistant prostate cancer. Demonstration of bioequivalence between a generic and reference formulation is essential to support regulatory approval and ensure therapeutic interchangeability. Objective: To evaluate the bioequivalence, safety, and tolerability of Abiraterone 500 mg Tablets compared with ZYTIGA® 500 mg tablets under fasting conditions in healthy adult male volunteers.