Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388239
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-04-24
Brief Title:
Bioequivalence Study of Apixaban 5 mg Film-coated Tablets in Healthy Thai Volunteers
Sponsor:
International Bio service
Organization:
International Bio service
Study Overview
Official Title:
A Single Dose Randomized Open-label Two-period Two-sequence Crossover Bioequivalence Study of Generic Apixaban 5 mg Film-coated Tablets and Reference Product ELIQUIS in Healthy Thai Volunteers Under Fasting Conditions
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
The goal of this bioequivalence of two formulations of generic apixaban 5 mg film-coated tablets Single-dose under fasting conditions and pharmacokinetics will be characterized for a total of 28 healthy adult human subjects Twenty-eight 28 subjects will be randomly assigned to receive either generic apixaban 5 mg film-coated tablets 1 x 5 mg Test or ELIQUIS 1 x 5 mg Reference in Period 1 and after the washout period they will receive the other formulation as a crossover fashion in Period 2
Detailed Description:
Twenty-eight 28 healthy adult male and female volunteers preferably with approximately equal numbers of each sex if possible 18 to 55 years will be enrolled from the general population Healthy adult male and female volunteers will be recruited in bioequivalence study as recommended in United States US Food and Drug Administration FDA Draft Guidance on Apixaban 11 Apixaban is a drug that can be used in any sex By these reasons normal healthy males and females as general population will be screened and 28 subjects will be recruited and enrolled into the study An attempt will be made by clinical study team to recruit subjects as per requirement
Remark The expected ratio of male to female subjects is 11 however if necessary the ratio can be varied but not more than 25 each
Remark The expected ratio of male to female subjects is 11 however if necessary the ratio can be varied but not more than 25 each
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