Embolism, Atrial Fibrillation and Venous Thrombosis
Conditions
Brief 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.
Interventions
Rivaroxaban granule15mg for one day
Rivaroxaban tablet15mg for one day
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of participants with adverse events as a measure of safety and tolerability | Up to 30 day |
Countries
Japan
Outcome results
None listed