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This clinical study will adopt an open-label, randomized, multiple-dose, two-crossover design to explore the pharmacokinetic and pharmacodynamic profiles of Vicagrel Capsules and Clopidogrel Tablets in Healthy Subjects with Different CYP2C19 Metabolizers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultra-rapid metabolizers group | Experimental | A 7-day cross-dosing of vicagrel and clopidogrel between two cycles |
|
| Rapid metabolizers group | Experimental | A 7-day cross-dosing of vicagrel and clopidogrel between two cycles |
|
| Normal metabolizers group | Experimental | A 7-day cross-dosing of vicagrel and clopidogrel between two cycles |
|
| Intermediate metabolizers group | Experimental | A 7-day cross-dosing of vicagrel and clopidogrel between two cycles |
|
| Poor metabolizers group | Experimental | A 7-day cross-dosing of vicagrel and clopidogrel between two cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vicagrel Capsules | Drug | Oral administration for 7 days under fasting |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inhibition of platelet aggregation [IPA] evaluated in healthy subjects to treatment with either vicagrel or clopidogrel | To compare IPA following multiple doses of vicagrel and/or clopidogrel in healthy subjects with different CYP2C19 phenotypes. | Day1-Day31 |
| Platelet reactivity index [PRI] evaluated in healthy subjects to treatment with either vicagrel or clopidogrel | To compare PRI following multiple doses of vicagrel and/or clopidogrel in healthy subjects with different CYP2C19 phenotypes. | Day1-Day31 |
| maximum plasma concentration (Cmax) | To compare Cmax following multiple doses of vicagrel and/or clopidogrel in healthy subjects with different CYP2C19 phenotypes. | Day1-Day31 |
| Area under the curve over a dosing interval(AUC0-tau) | To compare AUC0-tau following multiple doses of vicagrel and/or clopidogrel in healthy subjects with different CYP2C19 phenotypes. | Day1-Day31 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the safety and tolerability of multiple doses of both drugs in each CYP2C19 phenotype group. | Day1-Day31 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanhua Ding | Phase I Clinical Research Center of The First Hospital of Jilin University | Principal Investigator |
| Youngjun David Kim, MD | Altasciences Clinical, Los Angeles | Principal Investigator |
| Martin Kankam, MD | Altasciences, Kansas City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences Clinical, Los Angeles | Los Angeles | California | 90630 | United States | ||
| Altasciences, Kansas City |
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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 |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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Multiple-center, open-label, randomized, multiple-dose, crossover design
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| Clopidogrel Tablets | Drug | Oral administration for 7 days under fasting |
|
|
| Kansas City |
| Missouri |
| 66212 |
| United States |
| Phase I Clinical Research Center of The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |