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10.12.2018 | Original Article | Ausgabe 3/2019

Cancer Chemotherapy and Pharmacology 3/2019

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

Cancer Chemotherapy and Pharmacology > Ausgabe 3/2019
Chunhua Wang, Chaoying Hu, Dan Gao, Zirun Zhao, Xiaoping Chen, Xiao Hu, Shili Gong, Lin Li, Lan Zhang
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1007/​s00280-018-3754-x) contains supplementary material, which is available to authorized users.
Chunhua Wang and Chaoying Hu contributed equally to this work.



Abiraterone acetate is a highly variable drug and has been approved for the treatment of patients with metastatic castration-resistant prostate cancer in many countries. This study was conducted to compare the pharmacokinetic profile between the test product (abiraterone acetate tablet) and reference product ZYTIGA® (250 mg) mainly.


To overcome the high intra-subject variability of abiraterone, a two-sequence and four-period crossover study was designed to assess bioequivalence between the two products in 32 healthy male Chinese subjects under fasting conditions. The plasma concentration of abiraterone was analyzed by a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) assay and the reference-scaled procedure was used to determine bioequivalence for the pharmacokinetics parameters.


The point estimate of geometric mean ratios with 90% confidence interval (CI) of maximum observed concentration (Cmax) and the area under the concentration–time curve (AUC0t) for abiraterone in the test and reference products were 100.19% (90% CI 87.05–115.32%) and 105.99% (90% CI 96.34–116.62%), respectively, and were both within the range of 80.00–125.00%. The 95% confidence upper limit bound for \({({\bar {Y}_{\text{T}}} - {\overline {Y} _{\text{R}}})^{\text{2}}}~ - ~\theta S_{{{\text{WR}}}}^{{\text{2}}}{\text{ }}\) was − 0.1079 for Cmax and was − 0.0515 for AUC0t.


Bioequivalence was demonstrated between the two abiraterone acetate products. The study also confirmed high intra-subject variability, for abiraterone: coefficient of variation (CV, %) of Cmax values for the test and reference products were 40.33% and 46.58%, while for AUC0t were 24.02% and 34.16%, respectively.

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