Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2014-01-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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BAY59-7939 Rivaroxaban granule
Rivaroxaban (BAY 59-7939)
Rivaroxaban granule15mg for one day
BAY59-7939 Rivaroxaban tablet
Rivaroxaban (Xarelto, BAY 59-7939)
Rivaroxaban tablet15mg for one day
Interventions
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Rivaroxaban (BAY 59-7939)
Rivaroxaban granule15mg for one day
Rivaroxaban (Xarelto, BAY 59-7939)
Rivaroxaban tablet15mg for one day
Eligibility Criteria
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Inclusion Criteria
* 20 to 40 years of age
* 17.6 to 26.4 kg / m² of body mass index (BMI)
Exclusion Criteria
* 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)
20 Years
40 Years
MALE
Yes
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Kumamoto, Kumamoto, Japan
Countries
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Other Identifiers
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17017
Identifier Type: -
Identifier Source: org_study_id
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