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

NCT ID: NCT02273479

Last Updated: 2014-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-07-31

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Asasantin®

Group Type: EXPERIMENTAL

Asasantin®

Intervention Type: DRUG

Asasantin® extended release (RAD-SP)

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Asasantin®

Asasantin® extended release (RAD-SP)

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

9.127

Identifier Type: -

Identifier Source: org_study_id