Study Completed

embolism, atrial fibrillation and venous thrombosis

Bayer Identifier:

17017

ClinicalTrials.gov Identifier:

NCT02537457

EudraCT Number:

Not Available

EU CT Number:

Not Available

Bioequivalence study of Rivaroxaban

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.

Key Participants Requirements

Sex

Male

Age

20 - 40 Years

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

January 2014 - April 2014

Phase

Phase 1

Could I Receive a placebo

Products

Xarelto (Rivaroxaban, BAY59-7939)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	Medical Co. LTA Nishikumamoto hospital	Kumamoto, 861-4157, Japan

Primary Outcome

Cmax (maximum observed drug concentration in measured matrix after single dose administration)
Time Frame:
Multiple time point up to 3 day
Safety Issue:
No
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
Safety Issue:
No

Secondary Outcome

Number of participants with adverse events as a measure of safety and tolerability
Time Frame:
Up to 30 day
Safety Issue:
Yes

Trial design

Randomized, non-blinded, two-way crossover study to establish the bioequivalence between a rivaroxaban tablet 15 mg and a rivaroxaban granule 15 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

Additional Information

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