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Bioequivalence Study of Rivaroxaban in Japanese Healthy Adult Male Subjects

Primary Purpose

Embolism, Atrial Fibrillation and Venous Thrombosis

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Rivaroxaban (BAY 59-7939)
Rivaroxaban (Xarelto, BAY 59-7939)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Embolism, Atrial Fibrillation and Venous Thrombosis

Eligibility Criteria

20 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BAY59-7939 granule

BAY59-7939 tablet

Arm Description

Outcomes

Primary Outcome Measures

Cmax (maximum observed drug concentration in measured matrix after single dose administration)
AUC(0-tlast) (AUC from time 0 to the last data point > LLOQ (lower limit of quantitation))

Secondary Outcome Measures

Number of participants with adverse events as a measure of safety and tolerability

Full Information

First Posted
August 28, 2015
Last Updated
August 28, 2015
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT02537405
Brief Title
Bioequivalence Study of Rivaroxaban in Japanese Healthy Adult Male Subjects
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 Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Embolism, Atrial Fibrillation and Venous Thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BAY59-7939 granule
Arm Type
Experimental
Arm Title
BAY59-7939 tablet
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban (BAY 59-7939)
Intervention Description
Rivaroxaban granule 10mg for one day
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban (Xarelto, BAY 59-7939)
Intervention Description
Rivaroxaban tablet 10mg for one day
Primary Outcome Measure Information:
Title
Cmax (maximum observed drug concentration in measured matrix after single dose administration)
Time Frame
Multiple time point up to 3 day
Title
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 Measure Information:
Title
Number of participants with adverse events as a measure of safety and tolerability
Time Frame
Up to 30 day

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Kumamoto
ZIP/Postal Code
861-4157
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Bioequivalence Study of Rivaroxaban in Japanese Healthy Adult Male Subjects

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