Clinical trial NCT02273479: Pharmacokinetics and Safety of Asasantin Extended Release (RAD-SP) Capsules in Japanese Healthy Male Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-24
Enrollment: 32
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Area under the plasma drug concentration-time curve at steady state (AUCss)
timeFrame: up to 144 hours after first drug administration
measure: Maximum drug plasma concentration at steady state (Cmax,ss)
timeFrame: up to 144 hours after first drug administration
measure: Cmax,ss/AUCss
timeFrame: up to 144 hours after first drug administration
measure: Minimum drug plasma concentration at steady state (Cmin,ss)
timeFrame: up to 144 hours after first drug administration
measure: Time to reach Cmax (tmax)
timeFrame: up to 144 hours after first drug administration
measure: Terminal half-life (t1/2)
timeFrame: up to 144 hours after first drug administration
measure: Mean residence time (MRT)
timeFrame: up to 144 hours after first drug administration
measure: Percent peak trough fluctuation (%PTF)
timeFrame: up to 144 hours after first drug administration
Secondary outcomes:
measure: Platelet adenosine uptake inhibition rate (AUI)
timeFrame: up to 74 hours after first drug administration
measure: Malondialdehyde (MDA) production inhibition rate
timeFrame: up to 74 hours after first drug administration
measure: Thromboxane B2 (TXB2) production inhibition rate
timeFrame: up to 74 hours after first drug administration
measure: Number of subjects with adverse events
timeFrame: up to 14 days after first drug administration
measure: Number of subjects with abnormal changes in laboratory parameters
timeFrame: up to 14 days after first drug administration
measure: Number of subjects with abnormal changes in vital signs
timeFrame: up to 14 days after first drug administration
measure: Number of subjects with abnormal changes in electrocardiogram findings
timeFrame: up to 14 days after first drug administration
Other outcomes:
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