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

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

Official Title
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Pharmacokinetics and Safety of Asasantin Extended Release (RAD-SP) 200/25 mg Capsules b.i.d. in Randomised, Double-blind, Placebo-controlled Study in Japanese Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Asasantin®
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Asasantin®<br> | Drug: Asasantin®<br>* Asasantin® extended release (RAD-SP)<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma drug concentration-time curve at steady state (AUCss) |  | up to 144 hours after first drug administration | 
| Maximum drug plasma concentration at steady state (Cmax,ss) |  | up to 144 hours after first drug administration | 
| Cmax,ss/AUCss |  | up to 144 hours after first drug administration | 
| Minimum drug plasma concentration at steady state (Cmin,ss) |  | up to 144 hours after first drug administration | 
| Time to reach Cmax (tmax) |  | up to 144 hours after first drug administration | 
| Terminal half-life (t1/2) |  | up to 144 hours after first drug administration | 
| Mean residence time (MRT) |  | up to 144 hours after first drug administration | 
| Percent peak trough fluctuation (%PTF) |  | up to 144 hours after first drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet adenosine uptake inhibition rate (AUI) |  | up to 74 hours after first drug administration | 
| Malondialdehyde (MDA) production inhibition rate |  | up to 74 hours after first drug administration | 
| Thromboxane B2 (TXB2) production inhibition rate |  | up to 74 hours after first drug administration | 
| Number of subjects with adverse events |  | up to 14 days after first drug administration | 
| Number of subjects with abnormal changes in laboratory parameters |  | up to 14 days after first drug administration | 
| Number of subjects with abnormal changes in vital signs |  | up to 14 days after first drug administration | 
| Number of subjects with abnormal changes in electrocardiogram findings |  | up to 14 days after first drug administration |