Bioequivalence Study of Rivaroxaban in Japanese Healthy Adult Male Subjects

Embolism, Atrial Fibrillation and Venous Thrombosis Clinical Trial

Official title: Randomized, Non-blinded, Two-way Crossover Study to Establish the Bioequivalence Between a Rivaroxaban Tablet 10 mg and a Rivaroxaban Granule 10 mg in Japanese Healthy Adult Male Subjects

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Embolism, Atrial Fibrillation and Venous Thrombosis
• Venous Thrombosis

• NCT number: NCT02537405
• Study type: Interventional
• Source: Bayer
• Status: Completed
• Phase: Phase 1
• Start date: February 2014
• Completion date: April 2014