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The purpose of this study is to evaluate to determine the effect of food on the PK of a single dose of 250 mg Sulfatinib and its metabolites in healthy subjects.
The purpose of this study is to evaluate to determine the effect of food on the PK( pharmacokinetics) of a single dose of 250 mg Sulfatinib and its metabolites in healthy subjects and to assess the safety and tolerability of single doses of 250mg in healthy subjects.This study will be an open-label, randomized, two-period, crossover PK food effect study of Sulfatinib administered orally at 250 mg. Subjects will be screened for eligibility up to 14 days prior to entry into the study,there will be 2 treatments,2 weeks follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sulfatinib ,after general diet | Experimental | First cycle, single oral Sulfatinib after general diet intake; Second cycle, Sulfatinib before general diet intake. |
|
| Sulfatinib, before general diet | Experimental | First cycle, single oral Sulfatinib before general diet intake;Second cycle,single oral Sulfatinib after general diet intake |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulfatinib | Drug | 250mg Sulfatinib ,single dose,oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| The following PK parameters will be derived from the plasma concentration-time profile of Sufatinib following administration | Area Under Curve (AUC), both from time zero to time with last observation and from time zero to infinity;;Maximum plasma concentration (Cmax);Time to reach the Cmax (Tmax);elimination half-life | 1-3 days |
| Measure | Description | Time Frame |
|---|---|---|
| AE (adverse event) will be summarized by type and severity | 1 day to the 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chen Yu, Dr. | Xuhui Center Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | Shanghai Municipality | 200031 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32800383 | Derived | Qian H, Wu X, Chen Q, Li T, Wang W, Jia J, Yu C, Li K, Sai Y, Su W, Liu Y. Effects of Food on the Pharmacokinetic Properties of Surufatinib: A Phase I, Single-dose, Randomized, Open-label Crossover Study in Healthy Subjects. Clin Ther. 2020 Sep;42(9):1778-1786. doi: 10.1016/j.clinthera.2020.07.010. Epub 2020 Aug 13. |
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| ID | Term |
|---|---|
| C000717729 | surufatinib |
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