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Bioequivalence Study of Rivaroxaban in Japanese Healthy Adult Male Subjects

NCT02537405 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-09-01

No results posted yet for this study

Summary

The objectives of this study are to establish the bioequivalence between rivaroxaban tablet 10mg and rivaroxaban granule formulation 10mg, and to assess the safety and tolerability of rivaroxaban 10mg in healthy adult male subjects.

Conditions

  • Embolism, Atrial Fibrillation and Venous Thrombosis

Interventions

DRUG

Rivaroxaban (BAY 59-7939)

Rivaroxaban granule 10mg for one day

DRUG

Rivaroxaban (Xarelto, BAY 59-7939)

Rivaroxaban tablet 10mg for one day

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-03-31
Completion
2014-04-30

Countries

  • Japan

Study Locations

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Entities

Companies

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 NCT02537405 on ClinicalTrials.gov