Bioequivalence Study of Rivaroxaban in Japanese Healthy A... | NCT02537405

Studies
Bioequivalence Study of Rivaroxaban in Japanese Healthy Adult Male Subjects

NCT02537405

Sponsor

Bayer

Status

Completed

Last Update Posted

Sep 1, 2015Estimated

Enrollment

40Actual

Phase

Phase 1

Conditions

Embolism, Atrial Fibrillation and Venous Thrombosis

Interventions

Rivaroxaban (BAY 59-7939)
Rivaroxaban (Xarelto, BAY 59-7939)

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Mar 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Aug 28, 2015

First Submission Date that Met QC Criteria

Aug 28, 2015

First Posted Date

Sep 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2015

Last Update Posted Date

Sep 1, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BAY59-7939 granule	Experimental		Drug: Rivaroxaban (BAY 59-7939)
BAY59-7939 tablet	Active Comparator		Drug: Rivaroxaban (Xarelto, BAY 59-7939)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rivaroxaban (BAY 59-7939)	Drug	Rivaroxaban granule 10mg for one day	BAY59-7939 granule

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	Time Frame
Number of participants with adverse events as a measure of safety and tolerability		Up to 30 day

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Kumamoto	Kumamoto	861-4157	Japan

Condition Browse Module

MeSH Terms

ID	Term
D004617	Embolism
D001281	Atrial Fibrillation
D020246	Venous Thrombosis

Ancestor Terms

ID	Term
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001145	Arrhythmias, Cardiac

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069552	Rivaroxaban

Ancestor Terms

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D009025	Morpholines

Browse Leaves

Not provided

Browse Branches

Not provided