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Study to investigate pharmacokinetics, pharmacodynamics and safety of RAD-SP capsule in multiple administration to healthy adult male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asasantin® | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asasantin® | Drug | Asasantin® extended release (RAD-SP) |
| |
| Placebo |
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000068342 | Aspirin, Dipyridamole Drug Combination |
| ID | Term |
|---|---|
| D001241 | Aspirin |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 |
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| Drug |
|
| 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 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004176 | Dipyridamole |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |