Bioequivalence of Abiraterone Acetate Tablets in Healthy Chinese Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Abiraterone acetate tablets(Zecke ®250 mg);Abiraterone acetate tablets(250 mg)
Intervention type(s): Drug
Intervention description(s): 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.
Intervention MeSH terms: Abiraterone Acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: an open, randomized, single-dose, three-cycle, three-sequence crossover study
Masking: None (Open Label)
Primary purpose: Treatment