Pharmacokinetics and bioequivalence of generic and branded abiraterone acetate tablet: a single-dose, open-label, and replicate designed study in healthy Chinese male volunteers

ConclusionsBioequivalence was demonstrated between the two abiraterone acetate products. The study also confirmed high intra-subject variability, for abiraterone: coefficient of variation (CV, %) ofCmax values for the test and reference products were 40.33% and 46.58%, while for AUC0t were 24.02% and 34.16%, respectively.Trial registrationhttp://www.chinadrugtrials.org.cn/: CTR20170997.
Source: Cancer Chemotherapy and Pharmacology - Category: Cancer & Oncology Source Type: research