Bioequivalence Study of Rivaroxaban in Japanese Healthy Adult Male Subjects

• ClinicalTrials.gov Identifier: NCT02537405
• Recruitment Status: Completed
• First Posted: September 1, 2015
• Last Update Posted: September 1, 2015
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Embolism, Atrial Fibrillation and Venous Thrombosis	Drug: Rivaroxaban (BAY 59-7939); Drug: Rivaroxaban (Xarelto, BAY 59-7939)	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: February 2014
• Actual Primary Completion Date: March 2014
• Actual Study Completion Date: April 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: BAY59-7939 granule	Drug: Rivaroxaban (BAY 59-7939); Rivaroxaban granule 10mg for one day
Active Comparator: BAY59-7939 tablet	Drug: Rivaroxaban (Xarelto, BAY 59-7939); Rivaroxaban tablet 10mg for one day

Outcome Measures

Primary Outcome Measures :

1. Cmax (maximum observed drug concentration in measured matrix after single dose administration) [ Time Frame: Multiple time point up to 3 day ]
2. 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 ]

Secondary Outcome Measures :

1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 30 day ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 40 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

Japan

Kumamoto, Japan, 861-4157

Sponsors and Collaborators

Bayer

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT02537405
• Other Study ID Numbers: 17018
• First Posted: September 1, 2015
• Last Update Posted: September 1, 2015
• Last Verified: August 2015

Additional relevant MeSH terms:

Atrial Fibrillation; Thrombosis; Embolism; Venous Thrombosis; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Embolism and Thrombosis; Vascular Diseases; Rivaroxaban; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anticoagulants