Comparative Study of Abiraterone Acetate Tablets (I) or ZYTIGA® in Patients With Metastatic Castration-resistant Prostate Cancer

Summary

To evaluate whether the efficacy of the abiraterone acetate tablets (I) is comparable to that of the ZYTIGA®) by comparing the serum testosterone concentrations on Day 9 and/or Day 10 after oral administration of the two formulations in patients with metastatic castration-resistant prostate cancer (mCRPC).

Timeline

Start

2021-04-23

Primary completion

2021-10-21

Completion

2022-01-06

Outcome

Met primary endpoint

paper The 90% CI fell within the 80.0% to 125.0% equivalence limits, suggesting equivalent PD effect of the two formulations. PMID 40346626 ↗

Publications

• Lu X, Dai T, Chen X, Wu B, Chen H, Wu J, Yu D, Ge H, Li J, Huang H, Fan T, Cheng L, Zhang X, Zhang X, Yao X, Wei J, Xu Z, Yang W, He C, Luo J, Guan L, Fu B, Wang Q, Chen X, Zhang Y, Shi B, Zheng B, Wang Y, Luo H, Chen G, Wang H, Wang Q, Ye D. A randomized, open-label, multi-center, active-controlled phase II study comparing abiraterone acetate tablets (II), an improved formulation, versus originator abiraterone acetate in patients with metastatic castration-resistant prostate cancer. BMC Med. 2025 May 9;23(1):271. doi: 10.1186/s12916-025-04053-7.

Drugs

Indications