An open, randomized, single-dose, three-cycle, three-sequence crossover study was conducted in 36 healthy volunteers under fasting condition to evaluate the bioequivalence of two abiratone acetate tablets.
Abiraterone acetate tablet is an androgen synthesis inhibitor, primarily for the treatment of mCRPC. The objective of this study was to evaluate the pharmacokinetics and bioequivalence of two abiraterone acetate tablets in healthy Chinese subjects. In healthy subjects, a single-center, open, single-dose, randomized, three-cycle, three-sequence, semi-repeat (duplicate reference preparation only), reference formulation corrected fasting mean bioequivalence trial was conducted with a minimum of 7 days cleaning period between dosing. Blood samples were collected at prescribed time intervals, and the plasma concentration of abiraterone acetate tablet was determined by liquid chromatography-tandem mass spectrometry and adverse events were recorded. The pharmacokinetic parameters Cmax, Tmax, AUC0-t, AUC0-∞, T1/2 and so on were calculated by non-atrioventricular model. When the individual coefficient of variation(CVWR) of the pharmacokinetic parameters (AUC0-t, AUC0-∞ and Cmax) of reference formulation was less than 30%,with an average bioequivalence (ABE) criterion: if the test formulation and reference formulation of pharmacokinetic parameters (AUC0 - t,AUC0-∞ and Cmax) of the 90% CIs of GMR is not beyond the range of 80.00% -125.00%, which can determine the test formulation and reference formulation have bioequivalence.When the CVWR of the pharmacokinetic parameters (AUC0-t, AUC0-∞ and Cmax) of the reference preparation is greater than or equal to 30%,the reference preparation was used to correct for mean bioequivalence (RSABE): if the critbound of the pharmacokinetic parameters (AUC0-t,AUC0-∞ , Cmax) of the test formulations and reference formulations is less than 0, and the geometric average ratio is not beyond the range of 0.8000 - 1.2500, which can determine the test formulation and reference formulation have bioequivalence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Subjects were allocated to one of three groups randomly and equally with a 7-day washout interval between the two periods."Abiraterone acetate tablets(Zecke ® 250 mg,Batch number:VYCB manufactured by Patheon Inc.)and Abiraterone acetate tablets(250 mg,Batch number:17F0023DD9 manufactured by Qilu Pharmaceutical Co., Ltd) were used in this study.
Phase I Clinical Research Center
Qingdao, Shangdong, China
the ratios of geometrical mean
The two formulations are considered to be bioequivalent if the CVWR is less than 30% and 90% CIS of the ratio of primary pharmacokinetic parameters is within a predetermined acceptance range of 80% to 125%. If the CVWR of the pharmacokinetic parameters of the reference preparation is greater than or equal to 30%, Critbound ≤0, and the geometric mean ratio does not exceed the range of 0.8000 to 1.2500, the test preparation and the reference preparation can be determined to be bioequivalent.
Time frame: 30 Days
the occurrence rate of adverse events
Adverse events were recorded to evaluate the safety of the studied drugs.
Time frame: 30 Days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.