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This study is a single-center, randomized, open, two-cycle crossover, clopidogrel control, multiple dosing study. The aim was to evaluate the pharmacokinetic/pharmacodynamic behavior of different metabolites of CYP2C19 in healthy subjects. The study enrolled 48 patients, divided into three groups of CYP2C19 fast metabolite, middle metabolite, and slow metabolism, 16 cases in each group. All groups of subjects were administered for 7 days in the first cycle, once a day (loading dose on the first day, maintenance dose on other days), and entering the 14-day washout period after the end of the first cycle. The second cycle was entered, and the second cycle was administered for 7 days, once a day (the first day was given a loading dose, and the other days were given a maintenance dose). Blood was collected before and after administration of D1, D7, D22, and D28, and PK/PD was measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vicagrel | Experimental | Vicagrel 24mg loading followed by 6mg/day for 6 days |
|
| Clopidogrel | Active Comparator | Clopidogrel 300mg loading followed by 75mg/day for 6 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vicagrel 6mg | Drug | Vicagrel 24mg loading followed by 6mg/day for 6 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | To evaluate the Peak Plasma Concentration (Cmax) after taking drugs | 1 day,7 days after taking drugs |
| Area under the plasma concentration versus time curve (AUC) | To evaluate the AUC after taking drugsl | 1 day,7 days after taking drugs |
| Time to maximum plasma concentration (Tmax) | To evaluate the Tmax after taking drugs | 1 day,7 days after taking drugs |
| terminal half-life (T1/2) | To evaluate the T1/2 after taking drugs | 1 day,7 days after taking drugs |
| inhibition of platelet aggregation | To evluate the inhibition of platelet aggregation assessed by Verifynow System after taking drugs | 1 day,7 days after taking drugs |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | 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 |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Clopidogrel 75mg |
| Drug |
Clopidogrel 300mg loading followed by 75mg/day for 6 days |
|
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |