Trials / Completed
CompletedNCT04862091
Comparative Study of Abiraterone Acetate Tablets (I) or ZYTIGA® in Patients With Metastatic Castration-resistant Prostate Cancer
A Randomized, Open-Label, Multi-Center, Parallel Controlled Study Comparing the Serum Testosterone Levels in Patients With Metastatic Castration-Resistant Prostate Cancer After Oral Administration of Abiraterone Acetate Tablets (I) or ZYTIGA®
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 69 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Abiraterone Acetate Tablets (I) | Abiraterone Acetate Tablets (I) |
| DRUG | ZYTIGA® | ZYTIGA® |
Timeline
- Start date
- 2021-04-23
- Primary completion
- 2021-10-21
- Completion
- 2022-01-06
- First posted
- 2021-04-27
- Last updated
- 2022-03-04
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04862091. Inclusion in this directory is not an endorsement.