Back to resultsBioequivalence Study of Rivaroxaban
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
About this trial
This is an interventional treatment trial for Embolism, Atrial Fibrillation and Venous Thrombosis
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BAY59-7939 Rivaroxaban granule
BAY59-7939 Rivaroxaban 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
1. Study Identification
Unique Protocol Identification Number
NCT02537457
Brief Title
Bioequivalence Study of Rivaroxaban
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 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 15 mg and rivaroxaban granule formulation 15 mg, and to assess the safety and tolerability of rivaroxaban 15 mg 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 Rivaroxaban granule
Arm Type
Experimental
Arm Title
BAY59-7939 Rivaroxaban tablet
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban (BAY 59-7939)
Intervention Description
Rivaroxaban granule15mg for one day
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban (Xarelto, BAY 59-7939)
Intervention Description
Rivaroxaban tablet15mg 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
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