Bioequivalence Study of Rivaroxaban

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

The objectives of this study are to establish the bioequivalence between rivaroxaban tablet 15 mg and rivaroxaban granule formulation 15 mg, and to assess the safety and tolerability of rivaroxaban 15 mg in healthy adult male subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Rivaroxaban

Criteria

Inclusion Criteria:

• Japanese healthy male subjects

• 20 to 40 years of age

• 17.6 to 26.4 kg / m² of body mass index (BMI)

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)