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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
International Bio service·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Healthy Volunteer
Drug/Device/Intervention
Apixaban 5MG
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
International Bio service
Timeline & enrollment
Phase
Phase 1
Start date
Aug 26, 2024
End date
Sep 23, 2024
Enrollment
28 participants
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
Healthy person accompanying sick personRoutine general health check-up of armed forcesPersons encountering health services in other circumstancesPersons encountering health services in other circumstancesPerson encountering health services in unspecified circumstances
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06388239
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.