Overview
Bioequivalence Study of Rivaroxaban in Japanese Healthy Adult Male Subjects
Status:
Completed
Completed
Trial end date:
2014-04-01
2014-04-01
Target enrollment:
0
0
Participant gender:
Male
Male
Summary
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
BayerTreatments:
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)