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The purpose of this study is to assess the interaction between aspirin and Nexium in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Aspirin 81 mg |
|
| 2 | Active Comparator | Esomeprazole 20mg/aspirin 81mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | 81mg Tablet oral, once daily |
| |
| Esomeprazole |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effect of esomeprazole on low-dose aspirin pharmacodynamics by assessing the relative change in the VerifyNow Aspirin test after 5 days of treatment, relative to baseline (Day 1) in healthy human volunteers | Ongoing throughout the study from consent through withdrawal |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effect of esomeprazole on low-dose aspirin pharmacodynamics by assessing the relative change in serum thromboxane B2 inhibition from baseline | Ongoing throughout the study from consent through withdrawal | |
| Evaluate safety and tolerability of esomeprazole taken concurrently with low- dose aspirin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis N Morrison, MD | Bio-Kinetic Clinical Applications | Principal Investigator |
| Tore Lind | AstraZeneca | Study Director |
| Lynne Durborow | AstraZeneca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Springfield | Missouri | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22631032 | Derived | Andersson T, Morrison D, Nagy P, Pisupati J, Schettler J, Warner TD. Evaluation of the pharmacodynamics of acetylsalicylic acid 81 mg with or without esomeprazole 20 mg in healthy volunteers. Am J Cardiovasc Drugs. 2012 Aug 1;12(4):217-24. doi: 10.1007/BF03261830. |
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| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| ID | Term |
|---|---|
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Drug |
20 mg Tablet oral, once daily |
|
|
| Ongoing throughout the study from consent through withdrawal |
| D013272 | Stomach Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |