Trial Condition(s):

embolism, atrial fibrillation and venous thrombosis

Bioequivalence study of Rivaroxaban

Bayer Identifier:

17017

ClinicalTrials.gov Identifier:

NCT02537457

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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 Summary

Enrollment Goal
40
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Medical Co. LTA Nishikumamoto hospital

Kumamoto, Japan, 861-4157

Status
Completed
 

Trial Design