Bioequivalence Study of Rivaroxaban in Japanese Healthy Adult Male Subjects

Phase 1

Completed

• Conditions: Embolism, Atrial Fibrillation and Venous Thrombosis
• Interventions: Drug: Rivaroxaban (BAY 59-7939); Drug: Rivaroxaban (Xarelto, BAY 59-7939)

• Registration Number: NCT02537405
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2014-03
• Study Completion: 2014-04
• Status Verified: 2015-08
• Study First Submitted: 2015-08-28
• Study First Submitted QC: 2015-08-28
• Last Update Submitted: 2015-08-28
• Study First Posted: 2015-09-01
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Japanese healthy male subjects
• 20 to 40 years of age
• 17.6 to 26.4 kg / m² of body mass index (BMI)

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Exclusion Criteria

• Subject with incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
• Subject with a history of relevant diseases of vital organs, of the central nervous system or other organs, eg instable coronary heart disease, heart failure, liver failure, kidney failure, hypotension, or history of stroke or myocardial infarction
• Subject with known coagulation disorders (eg von Willebrand's disease, hemophilia)
• Subject with known disorders with increased bleeding risk (eg periodontosis, hemorrhoids, acute gastritis, peptic ulcer)
• Subject with known sensitivity to common causes of bleeding (eg nasal)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BAY59-7939 granule	Rivaroxaban (BAY 59-7939)	-
BAY59-7939 tablet	Rivaroxaban (Xarelto, BAY 59-7939)	-

Primary Outcome Measures

Name	Time	Method
Cmax (maximum observed drug concentration in measured matrix after single dose administration)	Multiple time point up to 3 day
AUC(0-tlast) (AUC from time 0 to the last data point > LLOQ (lower limit of quantitation))	Multiple time point up to 3 day

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events as a measure of safety and tolerability	Up to 30 day