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Comparison of pharmacokinetics of dipyridamole administered as Aggrenox versus dipyridamole administered as the immediate release formulation plus aspirin, under conditions of reduced stomach acidity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aggrenox | Experimental | extended release |
|
| dipyridamole+aspirin | Active Comparator | immediate release |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aggrenox | Drug |
| ||
| Dipyridamole |
| Measure | Description | Time Frame |
|---|---|---|
| area under the concentration time curve (AUC0-12) | up to 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| area under the concentration time curve 0-48 hours (AUC0-48) | up to 48 hours | |
| area under the concentration time curve extrapolated to infinity (AUC0-inf) | up to 3 days | |
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Inclusion Criteria:
Exclusion Criteria:
For female subjects:
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|
| Aspirin | Drug |
|
| Lansoprazole | Drug |
|
| maximum observed plasma concentration (Cmax) |
| up to 3 days |
| time to maximum observed plasma concentration (Tmax) | up to 3 days |
| terminal half life (t1/2) | up to 3 days |
| number of subjects with adverse events | up to 3 weeks |
| number of subjects with clinically significant changes in laboratory findings | up to 17 days |
| ID | Term |
|---|---|
| D000068342 | Aspirin, Dipyridamole Drug Combination |
| D004176 | Dipyridamole |
| D001241 | Aspirin |
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| 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 |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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