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This is a single-center, randomized, open-label study to compare the pharmacokinetic profiles of Famitinib and its metabolite SHR116637 at different doses/specifications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Famitinib Malate Capsules 10mg | Experimental |
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| Famitinib Malate Capsules 15mg | Experimental |
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| Famitinib Malate Capsules 20mg | Experimental |
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| Famitinib Malate Capsules 10mg*2 | Experimental |
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| Famitinib Malate Capsules 25mg | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Famitinib Malate Capsules | Drug | Famitinib Malate Capsules 10mg single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) for Famitinib after Single dose | from Day 1 to Day 9 after the first dose | |
| Area under the plasma concentration versus time curve (AUC0-t) for Famitinib after Single dose | from Day 1 to Day 9 after the first dose | |
| Area under the plasma concentration versus time curve (AUC0-∞) for Famitinib after Single dose | from Day 1 to Day 9 after the first dose | |
| Time to maximum observed plasma concentration (Tmax) for Famitinib after Single dose | from Day 1 to Day 9 after the first dose | |
| Elimination half-life (T1/2) for Famitinib after Single dose | from Day 1 to Day 9 after the first dose | |
| Apparent oral clearance (CL/F) for Famitinib after Single dose | from Day 1 to Day 9 after the first dose | |
| Apparent Volume of Distribution (Vz/F) Famitinib after Single dose | from Day1 to Day9 after the first dose | |
| Maximum observed plasma concentration (Cmax) for SHR116637 after Single dose | from Day 1 to Day 9 after the first dose | |
| Area under the plasma concentration versus time curve (AUC0-t) for SHR116637 after Single dose | from Day 1 to Day 9 after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events and severity of adverse events | from Day 1 to Day 16 after the first dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital Central South University | Changsha | Hunan | 410008 | China |
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| Famitinib Malate Capsules | Drug | Famitinib Malate Capsules 15mg single dose |
|
| Famitinib Malate Capsules | Drug | Famitinib Malate Capsules 20mg single dose |
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| Famitinib Malate Capsules | Drug | Famitinib Malate Capsules 10mg*2 single dose |
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| Famitinib Malate Capsules | Drug | Famitinib Malate Capsules 25mg single dose |
|
| Area under the plasma concentration versus time curve (AUC0-∞) for SHR116637 after Single dose | from Day 1 to Day 9 after the first dose |
| Time to maximum observed plasma concentration (Tmax) for SHR116637 after Single dose | from Day 1 to Day 9 after the first dose |
| Time to elimination half-life (T1/2) for SHR116637 after Single dose | from Day 1 to Day 9 after the first dose |
| Apparent oral clearance (CL/F) for SHR116637 after Single dose | from Day 1 to Day 9 after the first dose |
| Apparent Volume of Distribution (Vz/F) SHR116637 after Single dose | from Day 1 to Day 9 after the first dose |