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This study aims to evaluate the effects of tegoprazan or esomeprazole administered in combination with clopidogrel on the pharmacodynamics/Pharmacokinetics of clopidogrel in healthy adults
Evaluation Criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clopidogrel 75 mg | Active Comparator | Oral administration of clopidogrel 75 mg tablet once daily for 7 days |
|
| Clopidogrel 75 mg + Tegoprazan 25 mg | Experimental | Oral administration of clopidogrel 75 mg tablet and tegoprazan 25 mg tablet once daily for 7 days |
|
| Clopidogrel 75 mg + Esomeprazole 20 mg | Experimental | Oral administration of clopidogrel 75 mg tablet and esomeprazole 20 mg tablet once daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel 75 mg | Drug | Clopidogrel 75 mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in P2Y12 Reaction Unit (PRU) from baseline | Pharmacodynamic blood sampling to measure PRU using VerifyNow® system | Pre-dose(0h) on days 1, 3, 5, 7 and 8 in each period |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eun Ji Kim | Contact | 82-2-6477-0290 | eunji.kim24@inno-n.com | |
| Hee Hyun Kim | Contact | 82-2-6477-0258 | heehyun.kim@inno-n.com |
| Name | Affiliation | Role |
|---|---|---|
| Seung Hwan Lee | Seoul National University Hospital, Dept. of Clinical Pharmacology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital, Clinical Trial Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| C000631239 | tegoprazan |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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|
| Tegoprazan 25 mg | Drug | Tegoprazan 25 mg tablet |
|
|
| Esomeprazole 20mg | Drug | Esomeprazole 20 mg tablet |
|
|
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D001562 | Benzimidazoles |