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This clinical study will adopt a randomized, open-label, single-dose, 3-cycle, 3-way crossover design to explore the PK and PD profiles of a single oral dose of vicagrel capsules under fasted and fed conditions in health subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KGD | Experimental | Oral administration after fasting/high-fat meal/low-fat meal |
|
| GDK | Experimental | Oral administration after high-fat meal/low-fat meal/fasting |
|
| DKG | Experimental | Oral administration after low-fat meal/fasting/high-fat meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vicagrel | Drug | Oral administration after fasting/high-fat meal/low-fat meal |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC | Area Under the Curve From Time Zero to Last Quantifiable Concentration | 48 hours |
| Cmax | Peak concentration | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanhua Ding | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Changchun | Jilin | 130000 | China |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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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 |
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Single-center, randomized, open-label, single-dose, fasted/high-fat meal/low-fat meal, 3-cycle, 3-way crossover
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