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The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of Ensartinib Capsules.
The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of Ensartinib Capsules in Chinese Healthy Volunteers. In addition, the safety of Ensartinib Capsules 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: fed control → Period 2: fasted control | Experimental | Period 1: administration of Ensartinib 225mg at 7:30am, 30 minutes after the breakfast;Period 2: administration of Ensartinib 225mg at 7:30am, without the breakfast |
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| Period 1: fasted control → Period 2: fed control | Experimental | Period 1: administration of Ensartinib 225mg at 7:30am, without the breakfast;Period 2: administration of Ensartinib 225mg at 7:30am, 30 minutes after the breakfast |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ensartinib with fed or fasting | Drug | The two groups of subjects were given an equal dose of Ensartinib capsules (225 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 Ensartinib. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) of Ensartinib | The effect of food on Cmax after high fat diet and fasting Blood sampling over a 120 hour period post dose in all dosing sessions | pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour |
| Area under the plasma concentration versus time curve (AUC) of Ensartinib | The effect of food on AUC after high fat diet and fasting Blood sampling over a 120 hour period post dose in all dosing sessions | pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour |
| Time of maximum concentration(Tmax)of Ensartinib | The effect of food on Tmax after high fat diet and fasting Blood sampling over a 120 hour period post dose in all dosing sessions | pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour |
| Half life(T1/2)of Ensartinib | The effect of food on T1/2 after high fat diet and fasting Blood sampling over a 120 hour period post dose in all dosing sessions | pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of adverse events | Percentage of adverse events as assessed by CTCAE v4.0 | 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 |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000629294 | ensartinib |
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|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |