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The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of CM082 tablet.
The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of CM082 tablet in Chinese Healthy Volunteers. In addition, the safety of CM082 tablet in Chinese Healthy Volunteers who with High-fat meal or fasting state will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1: fasted control → Period 2: fed control | Experimental | Period 1: administration of CM082 200 mg at 7:30am, without the breakfast;Period 2: administration of CM082 200 mg at 7:30am, 30 minutes after the breakfast |
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| Period 1: fed control → Period 2: fasted control | Experimental | Period 1: administration of CM082 200 mg at 7:30am, 30 minutes after the breakfast;Period 2: administration of CM082 200 mg at 7:30am, without the breakfast |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM082 with fed or fasting | Drug | The two groups of subjects were given an equal dose of CM082 tablet (200 mg) after a single cross-over fasting or high-fat high-calorie diet in two different test cycles to examine the effect of food on the pharmacokinetics of CM082. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) of CM082 | The effect of food on Cmax after high fat diet and fasting Blood sampling over a 72 hour period post dose in all dosing sessions | pre-dose(30minute),30min、1、1.5、2、2.5、3、3.5、4、4.5、5、6、8、10、12、24、36、48、72hour (after administration) |
| Area under the plasma concentration versus time curve (AUC) of CM082 | The effect of food on AUC after high fat diet and fasting Blood sampling over a 72 hour period post dose in all dosing sessions | pre-dose(30minute),30min、1、1.5、2、2.5、3、3.5、4、4.5、5、6、8、10、12、24、36、48、72hour (after administration) |
| Time of maximum concentration(Tmax)of CM082 | The effect of food on Tmax after high fat diet and fasting Blood sampling over a 72 hour period post dose in all dosing sessions | pre-dose(30minute),30min、1、1.5、2、2.5、3、3.5、4、4.5、5、6、8、10、12、24、36、48、72hour (after administration) |
| Half life(T1/2)of CM082 | The effect of food on T1/2 after high fat diet and fasting Blood sampling over a 72 hour period post dose in all dosing sessions | pre-dose(30minute),30min、1、1.5、2、2.5、3、3.5、4、4.5、5、6、8、10、12、24、36、48、72hour (after administration) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of adverse events | Percentage of adverse events as assessed by CTCAE v4.03 | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| zourong ruan | the Second Affiliated Hospital of Zhejiang University Medical College | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 1st Phase Clinical Research Center of the Second Affiliated Hospital of Zhejiang University Medical College | Hangzhou | Zhejiang | 311009 | China |
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| ID | Term |
|---|---|
| C000709220 | vorolanib |
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