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Bioequivalence Study of Apixaban Tablets in Healthy Chinese Subjects

NCT05841446 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-05-03

No results posted yet for this study

Summary

To evaluate the single-center, open, randomized, single-dose, two-cycle, two-sequence, cross-over bioequivalence of test preparation apixaban tablet 2.5mg and reference preparation 2.5mg in healthy adult subjects in fasting and fed state

Conditions

  • Healthy

Interventions

DRUG

test apixaban tablets

specification: 2.5 mg, manufacturer: Disha Pharmaceutical Group Co., Ltd., Shandong, China

DRUG

reference apixaban tablets

specification: 2.5 mg, manufacturer: Bristol-Myers Squibb Manufacturing Company, USA

Sponsors & Collaborators

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-02
Primary Completion
2021-03-17
Completion
2021-04-07

Countries

  • China

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 NCT05841446 on ClinicalTrials.gov