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The study is a single-centre, randomized, open, 2-period, 2-sequence crossover design clinical trial. It is planned to enroll 28 healthy subjects.
Subjects will receive famitinib malate on Day1 and Day13.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group TR | Experimental | T - R |
|
| Treatment group RT | Experimental | R -T |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| famitinib malate T(5 mg*4)、famitinib malate R(20 mg) | Drug | TR Group: famitinib malate T on day 1, famitinib malate R on day 13. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of Famitinib | from Day1 to Day9 after the first cycle (each cycle is 9 days) and from Day13 to Day21 after the second cycle(each cycle is 9 days) | |
| Area under the plasma concentration versus time curve (AUC0-t) of Famitinib | from Day1 to Day9 after the first cycle(each cycle is 9 days) and from Day13 to Day21 after the second cycle(each cycle is 9 days) | |
| Area under the plasma concentration versus time curve (AUC0-∞) of Famitinib | from Day1 to Day9 after the first cycle(each cycle is 9 days) and from Day13 to Day21 after the second cycle(each cycle is 9 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum observed plasma concentration (Tmax) of Famitinib | from Day1 to Day9 after the first cycle(each cycle is 9 days) and from Day13 to Day21 after the second cycle(each cycle is 9 days) | |
| Elimination half-life (T1/2) of Famitinib | from Day1 to Day9 after the first cycle(each cycle is 9 days) and from Day13 to Day21 after the second cycle(each cycle is 9 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of USTC | Jinan | Jinan | 230001 | China |
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The study is a single-center, single-dose, randomized, open-label, two-cycle, crossover study.
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| famitinib malate T(5 mg*4)、famitinib malate R(20 mg) | Drug | RT Group: famitinib malate R on day 1, famitinib malate T on day 13. |
|
| Apparent oral clearance (CL/F) of Famitinib | from Day1 to Day9(each cycle is 9 days) after the first cycle and from Day13 to Day21 after the second cycle(each cycle is 9 days) |
| Maximum observed plasma concentration (Cmax) of SHR116637 | from Day1 to Day9 after the first cycle(each cycle is 9 days) and from Day13 to Day21 after the second cycle(each cycle is 9 days) |
| Area under the plasma concentration versus time curve (AUC0-t) of SHR116637 | from Day1 to Day9 after the first cycle(each cycle is 9 days) and from Day13 to Day21 after the second cycle(each cycle is 9 days) |
| Area under the plasma concentration versus time curve (AUC0-∞) of SHR116637 | from Day1 to Day9 after the first cycle(each cycle is 9 days) and from Day13 to Day21 after the second cycle(each cycle is 9 days) |
| Time to maximum observed plasma concentration (Tmax) of SHR116637 | from Day1 to Day9 after the first cycle(each cycle is 9 days) and from Day13 to Day21 after the second cycle(each cycle is 9 days) |
| Time to elimination half-life (T1/2) of SHR116637 | from Day1 to Day9 after the first cycle(each cycle is 9 days) and from Day13 to Day21 after the second cycle(each cycle is 9 days) |
| Apparent oral clearance (CL/F) of SHR116637 | from Day1 to Day9 after the first cycle(each cycle is 9 days) and from Day13 to Day21 after the second cycle(each cycle is 9 days) |
| Number of subjects with adverse events and the severity of adverse events | from Day1 to Day21 after the first dose |