Status:
COMPLETED
Bioequivalence Study in Healthy Subjects, 2*5 mg Tablets Rivaroxaban Versus 1*10 mg Tablet Rivaroxaban
Lead Sponsor:
Bayer
Collaborating Sponsors:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Therapeutic Equivalency
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The drug investigated in this study is Rivaroxaban, a novel, once-daily, oral anticoagulant for the prevention (prophylaxis) of deep vein thrombosis (DVT) which may lead to a pulmonary embolism (PE) i...
Eligibility Criteria
Inclusion
- Healthy male subjects
- 18 to 45 years of age
- Body mass index (BMI) between 18 and 30 kg/m2
Exclusion
- Conspicuous findings (medical history, screening)
- History of relevant diseases (internal organs, central nervous system or other organs)
- Medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor
- Febrile illness within 1 week before the start of the study
- History of severe allergies, non-allergic drug reactions, or multiple drug allergies
- Hypersensitivity to the investigational drug, the control agent and/or to inactive constituents
- Known coagulation disorders, known disorders with increased bleeding risk, known sensitivity to common causes of bleeding
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01436526
Start Date
August 1 2009
End Date
September 1 2009
Last Update
April 22 2015
Active Locations (1)
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1
Mönchengladbach, North Rhine-Westphalia, Germany, 41061