Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04863105
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2021-03-23
Brief Title:
Bioequivalence of Abiraterone Acetate Tablets in Healthy Chinese Volunteers
Sponsor:
The Affiliated Hospital of Qingdao University
Organization:
The Affiliated Hospital of Qingdao University
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- T12 and so on were calculated by non-atrioventricular model When the individual coefficient of variationCVWR of the pharmacokinetic parameters AUC0-t AUC0- and Cmax of reference formulation was less than 30with an average bioequivalence ABE criterion if the test formulation and reference formulation of pharmacokinetic parameters AUC0 - tAUC0- and Cmax of the 90 CIs of GMR is not beyond the range of 8000 -12500 which can determine the test formulation and reference formulation have bioequivalenceWhen the CVWR of the pharmacokinetic parameters AUC0-t AUC0- and Cmax of the reference preparation is greater than or equal to 30the reference preparation was used to correct for mean bioequivalence RSABE if the critbound of the pharmacokinetic parameters AUC0-tAUC0- Cmax of the test formulations and reference formulations is less than 0 and the geometric average ratio is not beyond the range of 08000 - 12500 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- T12 and so on were calculated by non-atrioventricular model When the individual coefficient of variationCVWR of the pharmacokinetic parameters AUC0-t AUC0- and Cmax of reference formulation was less than 30with an average bioequivalence ABE criterion if the test formulation and reference formulation of pharmacokinetic parameters AUC0 - tAUC0- and Cmax of the 90 CIs of GMR is not beyond the range of 8000 -12500 which can determine the test formulation and reference formulation have bioequivalenceWhen the CVWR of the pharmacokinetic parameters AUC0-t AUC0- and Cmax of the reference preparation is greater than or equal to 30the reference preparation was used to correct for mean bioequivalence RSABE if the critbound of the pharmacokinetic parameters AUC0-tAUC0- Cmax of the test formulations and reference formulations is less than 0 and the geometric average ratio is not beyond the range of 08000 - 12500 which can determine the test formulation and reference formulation have bioequivalence
Study Oversight
Has Oversight DMC:
None
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?:
None