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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: Asasantin®

• Registration Number: NCT02273479
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1999-07
• Primary Completion: 1999-09
• Status Verified: 2014-10
• Study First Submitted: 2014-10-23
• Study First Submitted QC: 2014-10-23
• Last Update Submitted: 2014-10-23
• Study First Posted: 2014-10-24
• Last Update Posted: 2014-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Asasantin®	Asasantin®	-

Primary Outcome Measures

Name	Time	Method
Minimum drug plasma concentration at steady state (Cmin,ss)	up to 144 hours after first drug administration
Mean residence time (MRT)	up to 144 hours after first drug administration
Cmax,ss/AUCss	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
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
Percent peak trough fluctuation (%PTF)	up to 144 hours after first drug administration

Secondary Outcome Measures

Name	Time	Method
Platelet adenosine uptake inhibition rate (AUI)	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 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
Number of subjects with abnormal changes in laboratory parameters	up to 14 days after first drug administration
Malondialdehyde (MDA) 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