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This study is a single-center, randomized, open label, 2×2 crossover design to assess the standard meal effects on PK of a single oral dose of VV119 in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A group | Experimental | Subjects will receive VV119 orally for single dose. |
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| B group | Experimental | Subjects will receive VV119 orally for single dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VV119 | Drug | A:2 mg VV119, following an overnight fast of at least 10 hours for Period 1; 2mg VV119, administered 30 minutes after the start of a Standard meal for Period 2; |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Incidence of Treatment-Emergent Adverse Events | Dosing through follow-up call (7 days after last dose of investigational product) |
| Cmax | maximum observed plasma concentration of the main metabolites VV119-M2 | 480 hours after dosing |
| AUC0-∞ | area under the plasma concentration time curve from time zero to infinity of the main metabolites VV119-M2 | 480 hours after dosing |
| AUC0-t | area under the plasma concentration time curve from time zero to the last of the main metabolites VV119-M2 | 480 hours after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huaqing Duan | Contact | +8618061926005 | huaqing.duan@vigonvita.cn |
| Name | Affiliation | Role |
|---|---|---|
| Huan Zhou | The First Affiliated Hospital of Anhui Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | China |
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| VV119 | Drug | B: 2mg VV119, administered 30 minutes after the start of a Standard meal for Period 1;2mg VV119, following an overnight fast of at least 10 hours for Period 2; |
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