Bioequivalence Study of Rivaroxaban in Japanese Healthy Adult Male Subjects

Bayer

Status and phase: Completed; Phase 1

Conditions: Embolism, Atrial Fibrillation and Venous Thrombosis

Treatments: Drug: Rivaroxaban (Xarelto, BAY 59-7939); Drug: Rivaroxaban (BAY 59-7939)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02537405

17018

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

BAY59-7939 granule

Experimental group

Treatment:

Drug: Rivaroxaban (BAY 59-7939)

BAY59-7939 tablet

Active Comparator group

Treatment:

Drug: Rivaroxaban (Xarelto, BAY 59-7939)