Bioequivalence Study of Rivaroxaban

Bayer40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Embolism, Atrial Fibrillation and Venous Thrombosis

Interventions

Rivaroxaban (BAY 59-7939)DRUG

Rivaroxaban granule15mg for one day

Rivaroxaban (Xarelto, BAY 59-7939)DRUG

Rivaroxaban tablet15mg for one day

Eligibility

Sex: MALEMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Unnamed facility

Kumamoto, Kumamoto, Japan

Outcomes

Primary Outcomes

Cmax (maximum observed drug concentration in measured matrix after single dose administration)

Time frame: Multiple time point up to 3 day

AUC(0-tlast) (AUC from time 0 to the last data point > LLOQ (lower limit of quantitation))

Time frame: Multiple time point up to 3 day

Secondary Outcomes

Number of participants with adverse events as a measure of safety and tolerability

Time frame: Up to 30 day

Data from ClinicalTrials.gov

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