Pharmacokinetics and Safety of Asasantin Extended Release (RAD-SP) Capsules in Japanese Healthy Male Volunteers

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

Study to investigate pharmacokinetics, pharmacodynamics and safety of RAD-SP capsule in multiple administration to healthy adult male volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Aspirin, Dipyridamole Drug Combination

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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