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This is a single-center, randomized, open, single-dose, three-cycle cross-design study, which will be only enrolled Chinese male healthy volunteers.
27-30 Chinese male healthy volunteers will be enrolled to assess the pharmacokinetic profile and relative bioavailability of 300 mg (50 mg x 6) Sulfatinib capsules of single dose orally in two different manufacturers after breakfast. All subjects are required to collect PK blood samples before and after administration at the following time points: within 1 hour before administration, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours after administration (16 times point), each collection of venous blood is 2mL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A-Sulfatinib T capsule | Experimental | The subjects in this arm will receive sulfatinib T capsules from Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd. |
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| Arm B-Sulfatinib R capsule | Experimental | The subjects in this arm will receive sulfatinib R capsules from Beijing Yiling Bioengineering Technology Co., Ltd. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulfatinib T capsule | Drug | Sulfatinib T capsules were produced by Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd. production. |
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| Measure | Description | Time Frame |
|---|---|---|
| The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration (AUCt) of Sulfatinib | The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration. | Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5 |
| Maximum observed plasma concentration (Cmax) of Sulfatinib | Maximum observed concentration, occurring at Tmax. | Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5 |
| The time to Cmax (peak time, Tmax) of Sulfatinib | The time at which maximum plasma concentration (Cmax) is observed. | Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5 |
| Half-life (t1/2) of Sulfatinib | The time required for the concentration of the drug to reach half of its original value. | Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5 |
| Relative Bioavailability | This term represents the relationship between the bioavailability of a substance in two different media. | Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event (AE) monitoring of Sulfatinib | AE monitoring will be assessed by incidence of AEs, AE grading, serious AEs, as well as laboratory determinations and vital sign parameters. | Measured from the date signed ICF to within 14 days after the last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liu Yanmei, Master | Shanghai Xuhui District Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui District Central Hospital | Shanghai | Shanghai Municipality | 200031 | China |
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| ID | Term |
|---|---|
| C000717729 | surufatinib |
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Eligible subjects who did not meet the exclusion criteria were randomly assigned to one of the three groups: group A, B, and C (administration TRR, RTR and RRT, 9 subjects in each group, where T is the test formulation and R is the reference formulation) .
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| Sulfatinib R capsule | Drug | Sulfatinib R capsules were produced by Beijing Yiling Bioengineering Technology Co., Ltd. |
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