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The primary objective of the study was to assess the effect of high-fat and low-fat meal on the pharmacokinetics of apatinib mesylate in Chinese adult healthy subjects.
The secondary objective of the study was to assess the safety of apatinib mesylate administered in adult healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Drug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after fasted, the second dose will be after low-fat meal, the third dose will be after high-fat meal |
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| Arm 2 | Experimental | Drug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after high-fat meal, the second dose will be after fasted, the third dose will be after low-fat meal |
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| Arm 3 | Experimental | Drug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after low-fat meal, the second dose will be after high-fat meal, the third dose will be after fasted |
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| Arm 4 | Experimental | Drug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after fasted, the second dose will be after high-fat meal, the third dose will be after low-fat meal |
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| Arm 5 | Experimental | Drug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after low-fat meal, the second dose will be after fasted, the third dose will be after high-fat meal |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib Mesylate | Drug | Single dose of apatinib mesylate after high-fat meal, low fat meal and fast |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum Observed Plasma Concentration for apatinib [ Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours ] | Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours |
| AUC0-t | Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for apatinib | Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours |
| AUC0-inf | Area Under the Plasma Concentration-time Curve from Time 0 to Infinite Time for apatinib | Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Luhe Hospital, Capital Medical University | Beijing | Beijing Municipality | 101100 | China |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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| Arm 6 | Experimental | Drug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after high-fat meal, the second dose will be after low-fat meal, the third dose will be after fasted |
|