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Comparative Pharmacokinetics of Asasantin Extended Release (ER) and of immediate release Persantin tablets combined with Acetyl salicylic acid (ASA) tablets
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asasantin (ER) | Experimental |
| |
| Combination of Persantin and ASA | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asasantin (ER) | Drug |
| ||
| Persantin |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve at steady state (AUCss) | Up to 144 hours after drug administration | |
| Percentage peak trough fluctuation (%PTF) | Up to 144 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration at steady state (Cmax,ss) of dipyridamole (dp) | Up to 144 hours after drug administration | |
| Maximum plasma concentration at steady state / Area under the plasma concentration-time curve at steady state ((Cmax,ss) / (AUCss)) of dipyridamole |
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Inclusion Criteria:
Exclusion Criteria:
For female subjects:
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|
| Acetyl salicylic acid (ASA) | Drug |
|
| Up to 144 hours after drug administration |
| Time to reach maximum plasma concentration at steady state (tmax,ss) of dipyridamole | Up to 144 hours after drug administration |
| Fluctuation of AUC (AUCfluct) of dipyridamole | Up to 144 hours after drug administration |
| Terminal half-life in the analyte (t1/2) of dipyridamole | Up to 144 hours after drug administration |
| Urinary excretion (Ae%) of dp, dipyridamole glucuronide (dp-gluc) and salicylic acid (SA) | Up to 106 hours after drug administration |
| Number of participants with abnormal changes in clinical laboratory parameters | Up to day 7 after last drug administration |
| Number of participants with Adverse Events | Up to day 7 after last drug administration |
| ID | Term |
|---|---|
| D000068342 | Aspirin, Dipyridamole Drug Combination |
| D004176 | Dipyridamole |
| ID | Term |
|---|---|
| D001241 | Aspirin |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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