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

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