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The primary objective is to evaluate the bioequivalence of famitinib malate capsules in new and old formulations after oral dose under fasted condition on healthy Chinese subjects.
The secondary objective is to evaluate the safety after famitinib malate capsules oral dose on healthy Chinese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group TR | Experimental | Intervention: Drug: famitinib malate, new formulation; Intervention: Drug: famitinib malate, old formulation. |
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| Treatment group RT | Experimental | Intervention: Drug: famitinib malate, old formulation; Intervention: Drug: famitinib malate, new formulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Famitinib malate | Drug | TR group: The first period,the subjects will be administrated with Famitinib malate in new formulation, then conduct blood collection within 192h; 14 days washout;The second period,the subjects will be administrated with Famitinib malate in old formulation, then conduct blood collection within 192h. RT group: The first period,the subjects will be administrated with Famitinib malate in old formulation, then conduct blood collection within 192h; 14 days washout;The second period,the subjects will be administrated with Famitinib malate in new formulation, then conduct blood collection within 192h. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameter: Cmax | Peak plasma concentration (Cmax) | through study completion, an average of 30 days |
| Pharmacokinetics parameter: AUC | Area under the plasma concentration versus time curve(AUC) | through study completion, an average of 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameter: Tmax | Time of maximum observed concentration (Tmax) | through study completion, an average of 30 days |
| Pharmacokinetics parameter: t1/2 | Half time (t1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital Beijing, Capital Medical University | Beijing | Beijing Municipality | 100053 | China |
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Treatment group TR Intervention: Drug: famitinib malate, new formulation; Intervention: Drug: famitinib malate, old formulation.
Treatment group RT Intervention: Drug: famitinib malate, old formulation; Intervention: Drug: famitinib malate, new formulation.
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| through study completion, an average of 30 days |
| Pharmacokinetics parameter: λz | First order elimination rate constant (λz) | through study completion, an average of 30 days |
| The number of participants with treatment-related adverse events assessed by CTCAE V5.0 | An adverse event is any untoward medical occurrence in the subjects or clinical study participants. | through study completion, an average of 30 days |