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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Asasantin®

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

9.127

Details and patient eligibility

About

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

Enrollment

32 patients

Sex

Male

Ages

20 to 35 years old

Volunteers

Accepts Healthy 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