Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT04863105
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2021-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence of Abiraterone Acetate Tablets in Healthy Chinese Volunteers
Sponsor:
The Affiliated Hospital of Qingdao University
Organization:
Study Overview
Official Title:
Bioequivalence of Abiraterone Acetate in Healthy Chinese Volunteers: an Open, Randomized, Single-dose, Three-cycle, Three-sequence Crossover Study
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: