Bioequivalence Study of Apixaban 5 mg Film-coated Tablets in Healthy Thai Volunteers - Trial NCT06388239
Access comprehensive clinical trial information for NCT06388239 through Pure Global AI's free database. This Phase 1 trial is sponsored by International Bio service and is currently Not yet recruiting. The study focuses on Healthy Volunteer. Target enrollment is 28 participants.
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Study Focus
Sponsor & Location
International Bio service
Timeline & Enrollment
Phase 1
Aug 26, 2024
Sep 23, 2024
Primary Outcome
Peak Plasma Concentration (Cmax) of Apixaban,Plasma Area Under the Curve AUC(0 to 36hr, AUC0-∞
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
 ELIQUISTM (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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06388239
Non-Device Trial