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The primary purpose of this study is to assess whether esomeprazole 20 mg/Acetyl Salicylic Acid (ASA) 81 mg affect the metabolism of clopidogrel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Treatment A (Clopidogrel 9 days), at least 14 days wash-out, Treatment B (Clopidogrel 4 days followed by Clopidogrel + Esomeprazole/ASA 5 days) |
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| 2 | Experimental | Treatment B (Clopidogrel 4 days followed by Clopidogrel + Esomeprazole/ASA 5 days), at least 14 days wash-out, Treatment A (Clopidogrel 9 days) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel | Drug | Clopidogrel |
| |
| Esomeprazole/ASA |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of esomeprazole 20 mg/ acetylsalicylic acid 81 mg on the pharmacodynamics of clopidogrel by assessing maximal inhibition of platelet aggregation after 9 days of clopidogrel treatment relative to baseline | Pharmacodynamic sampling will be done before treatment period 1. | |
| The effect of esomeprazole 20 mg/ acetylsalicylic acid 81 mg on the pharmacodynamics of clopidogrel by assessing maximal inhibition of platelet aggregation after 9 days of clopidogrel treatment relative to baseline | Pharmacodynamic sampling will be done after treatment period 1 | |
| The effect of esomeprazole 20 mg/ acetylsalicylic acid 81 mg on the pharmacodynamics of clopidogrel by assessing maximal inhibition of platelet aggregation after 9 days of clopidogrel treatment relative to baseline | Pharmacodynamic sampling will be done before treatment period 2. | |
| The effect of esomeprazole 20 mg/ acetylsalicylic acid 81 mg on the pharmacodynamics of clopidogrel by assessing maximal inhibition of platelet aggregation after 9 days of clopidogrel treatment relative to baseline | Pharmacodynamic sampling will be done after treatment period 2. |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of esomeprazole 20 mg/ acetylsalicylic acid 81 mg on the pharmacokinetics of the active metabolite of clopidogrel by assessing Area Under Curve (AUC) and Cmax.after 9 days of clopidogrel treatment | Pharmacokinetic sampling will be done at the end of treatment period 1 and 2 (Day 9). | |
| The safety and tolerability of clopidogrel alone and in combination with esomeprazole/ acetylsalicylic acid |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Nagy, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Uppsala | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24677117 | Derived | Andersson T, Nagy P, Niazi M, Nylander S, Galbraith H, Ranjan S, Wallentin L. Effect of esomeprazole with/without acetylsalicylic acid, omeprazole and lansoprazole on pharmacokinetics and pharmacodynamics of clopidogrel in healthy volunteers. Am J Cardiovasc Drugs. 2014 Jun;14(3):217-27. doi: 10.1007/s40256-014-0073-4. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Drug |
20 mg/81 mg once daily for five days (Day 5-9) |
|
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| Safety will be monitored continuously. Adverse events will be collected from the first administration of Investigational Product (IP) throughout the study until the follow-up visit (on average) 7-10 days after last dose. |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |