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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
69
Abiraterone Acetate Tablets (I)
ZYTIGA®
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Serum testosterone concentration
Blood Sample tested for Serum Testosterone Levels
Time frame: Day 9/Day 10
PSA level
The serum total PSA level
Time frame: 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.
Time frame: Day 28, Day 56, and Day 84
Absolute testosterone concentration
The actual measured serum testosterone concentration.
Time frame: 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
Time frame: Day 9/10, Day 28, Day 56, and Day 84
Steady-state minimum concentration of abiraterone
Defined as the plasma concentration of abiraterone
Time frame: Day 9/10, Day 28, Day 56, and Day 84
Cmax, ss
Defined as the steady-state maximum concentration
Time frame: Day 9
AUC0-τ
Defined as the area under the curve within the dosing interval at steady state
Time frame: Day 9
Cmin, ss
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Defined as the steady-state minimum concentration
Time frame: Day 9
Cav, ss
Defined as the mean blood drug concentration during the dosing interval at steady state
Time frame: Day 9