Status:
COMPLETED
Relative Bioavailability of Oral Suspension of Rivaroxaban Compared to Standard Tablet
Lead Sponsor:
Bayer
Collaborating Sponsors:
Janssen Research & Development, LLC
Conditions:
Biological Availability
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
Rivaroxaban is a substance developed for use in the treatment of blood coagulation disorders. Thrombosis (blood clots) can occur as a result of excessive coagulation activity in the blood vessels. Exc...
Eligibility Criteria
Inclusion
- Healthy male subjects
- Age: 18 to 55 years (inclusive) at the first screening examination
Exclusion
- 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
- Known coagulation disorders (eg von Willebrand's disease, hemophilia)
- Known disorders with increased bleeding risk (eg periodontosis, hemorrhoids, acute gastritis, peptic ulcer)
- Known sensitivity to common causes of bleeding (eg nasal)
- Regular use of medicines
- Clinically relevant findings in the ECG (electrocardiogram) such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QTc-interval over 450 msec
- Clinically relevant findings in the physical examination
- Clinically relevant deviations of the screened laboratory parameters from reference ranges
- Participation in another clinical study during the preceding 3 months (Last Treatment from previous study to First Treatment of new study)
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01853800
Start Date
May 1 2013
End Date
August 1 2013
Last Update
January 23 2017
Active Locations (1)
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1
Wuppertal, North Rhine-Westphalia, Germany, 42096