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This study is a single-center, randomized, open label, 3×3 crossover design to assess the high-fat meal and the standard meal effects on PK of a single oral dose of VV913 in healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A group | Experimental |
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| B group | Experimental |
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| C group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VV913 | Drug | A group:5 mg VV913, following an overnight fast of at least 10 hours for Period 1 ; 5 mg VV913, administered 30 minutes after the start of a Standard meal for Period 2 ; 5 mg VV913, administered 30 minutes after the start of the high-fat meal for Period 3; |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Incidence of Adverse Events | From dosing to follow-up call (4 days after last dose of VV913) |
| Cmax | maximum observed plasma concentration of VV913 | 72 hours after dosing |
| AUC0-∞ | area under the plasma concentration time curve from time zero to infinity of VV913 | 72 hours after dosing |
| AUC0-t | area under the plasma concentration time curve from time zero to the last of VV913 | 72 hours after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huaqing Duan | Contact | 18061926005 | huaqing.duan@vigonvita.cn |
| Name | Affiliation | Role |
|---|---|---|
| Huan Zhou | The First Affiliated Hospital of Anhui Medical University | Principal Investigator |
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| VV913 | Drug | B group:5 mg VV913, administered 30 minutes after the start of the high-fat meal for Period 1 ; 5 mg VV913, following an overnight fast of at least 10 hours for Period 2 ; 5 mg VV913, administered 30 minutes after the start of a Standard meal for Period 3; |
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| VV913 | Drug | C group:5 mg VV913, administered 30 minutes after the start of a Standard meal for Period 1;5 mg VV913, administered 30 minutes after the start of the high-fat meal for Period 2 ; 5 mg VV913, following an overnight fast of at least 10 hours for Period 3 ; |
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