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The primary objective of the study is to evaluate the effects of omeprazole on the PK and PD of a single dose of vicagrel in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vicagrel and omeprazole | Experimental | D1 single dose of vicagrel was administered. Omeprazole administration was started on D4, once daily for 5 days, and a single dose of vicagrel and omeprazole coadministration on day 9. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vicagrel and omeprazole | Drug | 18 mg vicagrel capsules and 40 mg omeprazole magnesium enteric-coated tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inhibition of platelet aggregation [IPA] evaluated in healthy subjects to treatment with vicagrel | Day 2 of each period | |
| Platelet reactivity index [PRI] evaluated in healthy subjects to treatment with vicagrel | Day 2 of each period | |
| maximum plasma concentration (Cmax) | Up to 48 hours postdose on Day 3 for each period | |
| Area under the concentration-time curve (AUC) | Up to 48 hours postdose on Day 3 for each period |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the safety of a single dose of vicagrel and a combination of vicagrel and omeprazole in healthy subjects by assessment of adverse events and symptoms and physical examination, clinical laboratory tests, vital signs,12-ECG. | Day1-Day11 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Fei, 130021 | Contact | 0431-88786014 | wangfei5780@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phase I Clinical Research Center of The First Hospital of Jilin University | Recruiting | Changchun | Jilin | China |
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| ID | Term |
|---|---|
| C574646 | methyl 2-(2-acetoxy-6,7-dihydrothieno(3,2-c)pyridin-5(4H)-yl)-2-(2-chlorophenyl)acetate |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |