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This study has an open-label, five-period, single-sequence design. The purpose of this study is as follows;
Primary
Secondary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clopidogrel+Aspirin | Experimental | Clopidogrel on Day 1, Aspirin on Day 2 - Day 14, Clopidogrel + Aspirin Day 15, Aspirin on Day 16 - Day 28, Clopidogrel + Aspirin Day 29 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel+Aspirin | Drug | Clopidogrel 75 mg, Aspirin 100 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of Clopidogrel | Plasma concentration of clopidogrel and active metabolite of clopidogrel | Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h postdose on Day 1, Day 15 and Day 29 |
| Pharmacodynamics of clopidogrel | Relative inhibition of platelet aggregation by aggregometer or VerifyNow | Predose and 4, 24 h postdose on Day 1, Day 15 and Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| mRNA/microRNA/endogenous metabolite | mRNA of PON1 and CYP2C19, CYP3A5, MDR1 microRNA endogenous metabolite | predose on Day 1, Day 8, Day 15, Day 22 and Day 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| In-Jin Jang, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital Clinical Trials Center | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24566733 | Derived | Oh J, Shin D, Lim KS, Lee S, Jung KH, Chu K, Hong KS, Shin KH, Cho JY, Yoon SH, Ji SC, Yu KS, Lee H, Jang IJ. Aspirin decreases systemic exposure to clopidogrel through modulation of P-glycoprotein but does not alter its antithrombotic activity. Clin Pharmacol Ther. 2014 Jun;95(6):608-16. doi: 10.1038/clpt.2014.49. Epub 2014 Feb 24. |
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