NCT06388239

Bioequivalence Study of Apixaban 5 mg Film-coated Tablets in Healthy Thai Volunteers

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: International Bio service · Network
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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will be recruited in bioequivalence study as recommended in United States (US) Food and Drug Administration (FDA), Draft Guidance on Apixaban.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 1:1; however, if necessary, the ratio can be varied but not more than 25% each.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Apixaban 5MG	Apixaban 5 mg Film-coated tablets

Timeline

• Start date: 2024-08-26
• Primary completion: 2024-09-14
• Completion: 2024-09-23
• First posted: 2024-04-29
• Last updated: 2024-05-24