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Bioequivalence Study of Two Products of Apixaban 5mg Tablets in Healthy, Adult, Human Subjects

NCT06043297 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-15

No results posted yet for this study

Summary

To compare the bioavailability and characterize the pharmacokinetic profile of the sponsor's test product relative to that of reference product after single oral dose administration in normal, healthy, adult, human subjects under fasting condition and to assess the bioequivalence.

Conditions

  • Antithrombic Drug

Interventions

DRUG

Apixaban 5MG

Each film-coated tablet contains 5 mg apixaban

DRUG

Eliquis 5 mg

Each film-coated tablet contains 5 mg apixaban

Sponsors & Collaborators

  • Yunus sancak

    collaborator UNKNOWN

  • Humanis Saglık Anonim Sirketi

    lead INDUSTRY

Principal Investigators

  • Hakan Gürpınar · Humanis Saglık

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-02-23
Primary Completion
2023-03-06
Completion
2023-04-27

Countries

  • India

Study Locations

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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 NCT06043297 on ClinicalTrials.gov