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This study evaluates the food-effect of one-dose Fluzoparib in healthy subjects. The participants receive Fluzoparib 120mg in fed state in Period 1 followed by administration of Fluzoparib 120mg in fasted state in Period 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Administration of 120mg in fed state in Dosing Period 1 followed by administration of 120mg in fasted state in Dosing Period 2 |
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| Group B | Experimental | Administration of 120mg in fasted state in Dosing Period 1 followed by administration of 120mg in fed state in Dosing Period 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzoparib | Drug | 2 doses separated by 7 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics - Cmax | This study was designed to estimate the relative bioavailability of Fluzoparib 120 mg in the fed state relative to the fasted state.Peak Plasma Concentration (Cmax) and the the 90% confidence interval were calculated. | pre-dose and then 0.25、0.5、1、1.5、2、3、4、6、8、10、12、24、36、48、72、96h |
| Pharmacokinetics-AUC | This study was designed to estimate the relative bioavailability of Fluzoparib 120 mg in the fed state relative to the fasted state.Area under the plasma concentration versus time curve (AUC0-last,AUC0-infinity) and the 90% confidence intervals were calculated. | pre-dose and then 0.25、0.5、1、1.5、2、3、4、6、8、10、12、24、36、48、72、96h |
| Pharmacokinetics - Tmax (Hours) | To estimate the the time to Maximum concentration and constructe the corresponding 90% confidence intervals. | pre-dose and then 0.25、0.5、1、1.5、2、3、4、6、8、10、12、24、36、48、72、96h |
| Collection of Feces and Urine and Measurement of 120mg Fluzoparib Metabolism in Healthy subjects by HPLC | This study was also designed to clarify the metabolism of Fluzoparib 120mg. | 0-96h post dose if availabel |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Hosital of Jilin University | Changchun | Jilin | China |
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| ID | Term |
|---|---|
| C000722917 | fluzoparib |
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