NCT04863105

Bioequivalence of Abiraterone Acetate Tablets in Healthy Chinese Volunteers

Bioequivalence of Abiraterone Acetate in Healthy Chinese Volunteers: an Open, Randomized, Single-dose, Three-cycle, Three-sequence Crossover Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Abiraterone acetate tablets(Zecke ®250 mg);Abiraterone acetate tablets(250 mg)	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.

Timeline

• Start date: 2017-11-24
• Primary completion: 2017-12-25
• Completion: 2018-04-09
• First posted: 2021-04-28
• Last updated: 2021-04-28

Locations

1 site across 1 country: China