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Bioequivalence Study of Apixaban 5 mg Film-Coated Tablet

NCT06817811 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-02-10

No results posted yet for this study

Summary

This was an open-label, randomized, single-dose, two-period, two-sequence, cross-over study under fasting condition which included 24 healthy adult male and female subjects. The objective of this study was to find out whether the bioavailability of apixaban 5 mg film-coated tablet produced by PT Dexa Medica in comparison with the comparator drug (Eliquis® 5 mg filmcoated tablet, Bristol-Myers Squibb Company, Puerto Rico, packed and released by Bristol Myers Squibb S.r.l., Italy, imported by PT Pfizer Indonesia).

Conditions

  • Health

Interventions

DRUG

Apixaban 5 mg Film-Coated Tablet (produced by PT Dexa Medica)

One tablet of the test drug was given orally under fasting condition

DRUG

Eliquis® 5 mg film-coated tablet (Bristol-Myers Squibb Company, Puerto Rico, packed and released by Bristol-Myers Squibb S.r.l., Italy, imported by PT Pfizer Indonesia)

One tablet of the reference drug was given orally under fasting condition

Sponsors & Collaborators

  • PT Equilab International

    collaborator INDUSTRY

  • Dexa Medica Group

    lead INDUSTRY

Principal Investigators

  • Danang A Yunaidi · PT Equilab International

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
2021-04-15
Primary Completion
2021-04-24
Completion
2021-06-03

Countries

  • Indonesia

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 NCT06817811 on ClinicalTrials.gov