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| Name | Class |
|---|---|
| H & J CRO International, Inc. | INDUSTRY |
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The purpose of this study is to further study the pharmacokinetic characteristics of Chiauranib Capsule in Healthy Volunteers with High Fat Diet.
This study is a Randomized, Open-label, Single-dose, Single-center, two-sequence, two- stage Phase I Trial. 16 Healthy Volunteers will be enrolled and Randomized into two arms. 8 Healthy Volunteers were in each arm. Arm A:Patients receive 50mg Chiauranib po only once In the fasting state and after 14 days receive 50mg Chiauranib po Only once with High Fat Diet. Arm B: Patients receive 50mg Chiauranib po only once with High Fat Diet and after 14 days receive 50mg Chiauranib po Only once In the fasting state. During the trial, Blood samples were collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chiauranib(In the fasting state) | Other | Experimental: Chiauranib Patients receive 50mg Chiauranib po only once In the fasting state and after 14 days receive 50mg Chiauranib po Only once with High Fat Diet |
|
| Chiauranib(In the high fat diet state) | Other | Experimental: Chiauranib Patients receive 50mg Chiauranib po only once with High Fat Diet and after 14 days receive 50mg Chiauranib po Only once In the fasting state |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chiauranib | Drug | 50mg po only once |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of Chiauranib (in plasma) | Peak plasma concentration for Chiauranib(Cmax) | up to 20 Days |
| Pharmacokinetics of Chiauranib (in plasma) | Area under the concentration-time curve from zero to last quantificable concentration for Chiauranib (AUC0-t) | up to 20 Days |
| Pharmacokinetics of Chiauranib (in plasma) | Area under the concentration-time curve from zero extrapolated to infinity for Chiauranib(AUC0-inf) | up to 20 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of Chiauranib (in plasma) | Time to Cmax for Chiaruanib(Tmax) | up to 20 Days |
| Pharmacokinetics of Chiauranib (in plasma) | Elimination half-life(t1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| LiYan Miao | First Affiliated Hospital of Suzhou Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Suzhou University | Suzhou | Jiangsu | 21500 | China |
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| ID | Term |
|---|---|
| C000705608 | chiauranib |
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| up to 20 Days |
| Pharmacokinetics of Chiauranib (in plasma) | Apparent clearance(CL/F) | up to 20 Days |
| Pharmacokinetics of Chiauranib (in plasma) | Apparent volume of distribution(Vd/F) | up to 20 Days |
| Pharmacokinetics of Chiauranib (in plasma) | Elimination rate constant(λz) | up to 20 Days |