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The main objective of this study is to evaluate the bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers.
The main objective of this study is to evaluate the bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers under fasted state or after meal. In addition, the safety of single dose administration of CM082 tablet in Chinese healthy volunteers will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T-R cohort under fasted state | Experimental | Subjects will be administered with one single dose of CM082 tablet (test product) under fasted state, after a wash period of 5 days, the subjects will be administered with one single dose of CM082 tablet (reference product) under fasted state. |
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| R-T cohort under fasted state | Experimental | Subjects will be administered with one single dose of CM082 tablet (reference product) under fasted state, after a wash period of 5 days,the subjects will be administered with one single dose of CM082 tablet (test product) under fasted state. |
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| T-R cohort after meal | Experimental | Subjects will be administered with one single dose of CM082 tablet (test product) after meal, after a wash period of 5 days,the subjects will be administered with one single dose of CM082 tablet (reference product) after meal. |
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| R-T cohort after meal | Experimental | Subjects will be administered with one single dose of CM082 tablet (reference product) after meal, after a wash period of 14 days,the subjects will be administered with one single dose of CM082 tablet (test product) after meal |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM082 tablet (test product) | Drug | Test product(T):100mg CM082 tablet manufactured by Betta Pharmaceuticals |
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| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration(Cmax) of CM082 (test product or reference product) under fasted state or after meal | The Cmax ofCM082 (test product or reference product) in under fasted state or after meal blood samples of each subject over a 72 hour period post dose | pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,10,12,16,24,36,48,72 hour] |
| Area under the plasma concentration versus time curve(AUC) of CM082 (test product or reference product) under fasted state or after meal | The AUC of CM082 (test product or reference product) in under fasted state or after meal blood samples of each subject over a 72 hour period post dose | pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,10,12,16,24,36,48,72 hour] |
| Time of maximum concentration (Tmax) of CM082 (test product or reference product) under fasted state or after meal | The Tmax of CM082 (test product or reference product) in under fasted state or after meal blood samples of each subject over a 72 hour period post dose | pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,10,12,16,24,36,48,72 hour] |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of adverse events | Percentage of adverse events as assessed by CTCAE v4.03 | From the first occurrence of adverse events after administration to the cessation of adverse events, 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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| CM082 tablet (reference product) | Drug | Reference product(R):100mg CM082 tablet manufactured by Catalent Pharma Solutions |
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