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Pharmacokinetics and Bioequivalence of Rivaroxaban Tablet in Healthy Chinese Volunteers

NCT04424381 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2020-06-11

No results posted yet for this study

Summary

The study was designed as a single-site, randomized, open-label, four-period complete and replicate crossover. A single oral dose of 20 mg rivaroxaban tablet (test) and Xarelto®(reference) was given to the 72 healthy Chinese adult volunteers, with 36 in a fasting state and 36 receiving a high-fat diet.

Conditions

  • Healthy Subjects

Interventions

DRUG

Rivaroxaban 20 MG Oral Tablet [Xarelto]

The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet \[Xarelto\].

DRUG

Rivaroxaban 20 MG Oral Tablet

The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet.

Sponsors & Collaborators

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Principal Investigators

  • yu Cao · the study director of phase I clinical research center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-06-04
Primary Completion
2019-09-05
Completion
2019-09-20

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 NCT04424381 on ClinicalTrials.gov