Bioequivalence Study of Apixaban 5 mg Film-coated Tablets in Healthy Thai Volunteers
Status:
NOT_YET_RECRUITING
Trial end date:
2024-09-23
Target enrollment:
Participant gender:
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.