Bioequivalence Study of Rivaroxaban in Japanese Healthy Adult Male Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02537405

Enrollment

Registered

2015-09-01

Start date

2014-02-28

Completion date

2014-04-30

Last updated

2015-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Embolism, Atrial Fibrillation and Venous Thrombosis

Brief 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.

Interventions

DRUGRivaroxaban (BAY 59-7939)

Rivaroxaban granule 10mg for one day

DRUGRivaroxaban (Xarelto, BAY 59-7939)

Rivaroxaban tablet 10mg for one day

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

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026