Status:
COMPLETED
Pharmacokinetics and Safety of Asasantin Extended Release (RAD-SP) Capsules in Japanese Healthy Male Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
20-35 years
Phase:
PHASE1
Brief Summary
Study to investigate pharmacokinetics, pharmacodynamics and safety of RAD-SP capsule in multiple administration to healthy adult male volunteers.
Eligibility Criteria
Inclusion
- Healthy male volunteers judged by the investigator as appropriate subjects on the basis of screening test results
- Age range: ≥ 20 years and ≤ 35 years
- Body weight between 50 and 80 kg
- Obesity is within ± 20% of the standard body weight
- Ability to provide written informed consent to participate in the study
Exclusion
- History of drug allergy
- History of bronchial asthma
- History of drug abuse and alcohol abuse
- History of hemorrhagic tendency or hemorrhagic disease
- Volunteers who have experiences in playing sports such as boxing which may damage the brain
- Accidents associated with brain concussion and contusion (traffic accident, etc.)
- Administration of other study drug within 4 months before start of administration of this study drug
- Collection of whole blood (≥ 400 ml) within 3 months before study drug administration
- Collection of component blood (≥ 400 ml) within 1 months before study drug administration
- Intake of some drug or other within 10 days before the study drug administration
- Excessive physical activities within the last 5 days prior to study drug administration
- Intake of alcohol within 3 days before study drug administration
- Volunteers judged by the investigator to be inappropriate as the subjects of study
Key Trial Info
Start Date :
July 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02273479
Start Date
July 1 1999
Last Update
October 24 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.