Healthy
Conditions
Brief summary
Study to investigate pharmacokinetics, pharmacodynamics and safety of RAD-SP capsule in multiple administration to healthy adult male volunteers.
Interventions
DRUGAsasantin®
Asasantin® extended release (RAD-SP)
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent peak trough fluctuation (%PTF) | 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Platelet adenosine uptake inhibition rate (AUI) | up to 74 hours after first drug administration |
Outcome results
None listed