Trial Condition(s):
embolism, atrial fibrillation and venous thrombosis
Bioequivalence study of Rivaroxaban in Japanese healthy adult male subjects
Bayer Identifier:
17018
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Medical Co. LTA Nishikumamoto hospital Kumamoto, Japan, 861-4157 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Randomized, non-blinded, two-way crossover study to establish the bioequivalence between a rivaroxaban tablet 10 mg and a rivaroxaban granule 10 mg in Japanese healthy adult male subjects
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
2
Primary Outcome
- Cmax (maximum observed drug concentration in measured matrix after single dose administration)Timeframe: Multiple time point up to 3 day
- AUC(0-tlast) (AUC from time 0 to the last data point > LLOQ (lower limit of quantitation))Timeframe: Multiple time point up to 3 day
Secondary Outcome
- Number of participants with adverse events as a measure of safety and tolerabilityTimeframe: Up to 30 day
Additional Information
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