Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abiraterone Acetate Tablets (I) | Experimental |
| |
| ZYTIGA®. | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abiraterone Acetate Tablets (I) | Drug | Abiraterone Acetate Tablets (I) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Serum testosterone concentration | Blood Sample tested for Serum Testosterone Levels | Day 9/Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| PSA level | The serum total PSA level | Day 28, Day 56, and Day 84 |
| PSA-50 response rate | The percentage of subjects with total serum PSA level decreased by 50% from the baseline value. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200433 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40346626 | Derived | 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. |
Not provided
Not provided
Not provided
Abiraterone Acetate Tablets (I) compared with ZYTIGA®
Not provided
Not provided
Not provided
Not provided
| ZYTIGA® |
| Drug |
ZYTIGA® |
|
| Day 28, Day 56, and Day 84 |
| Absolute testosterone concentration | The actual measured serum testosterone concentration. | Day 9/10, Day 28, Day 56, and Day 84 |
| Testosterone inhibition rate | The percentage of subjects with a serum testosterone concentration of ≤ 1 ng/dL | Day 9/10, Day 28, Day 56, and Day 84 |
| Steady-state minimum concentration of abiraterone | Defined as the plasma concentration of abiraterone | Day 9/10, Day 28, Day 56, and Day 84 |
| Cmax, ss | Defined as the steady-state maximum concentration | Day 9 |
| AUC0-τ | Defined as the area under the curve within the dosing interval at steady state | Day 9 |
| Cmin, ss | Defined as the steady-state minimum concentration | Day 9 |
| Cav, ss | Defined as the mean blood drug concentration during the dosing interval at steady state | Day 9 |
| ID | Term |
|---|---|
| D000069501 | Abiraterone Acetate |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided