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

NCT06388239 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-05-24

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer

Interventions

DRUG

Apixaban 5MG

Apixaban 5 mg Film-coated tablets

Sponsors & Collaborators

  • International Bio service

    lead NETWORK

Principal Investigators

  • Porranee Puranajoti, Ph. D · International Bio Service Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-26
Primary Completion
2024-09-14
Completion
2024-09-23

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06388239 on ClinicalTrials.gov