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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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.
The 1st Phase Clinical Research Center of the Second Affiliated Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, China
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Percentage of adverse events
Percentage of adverse events as assessed by CTCAE v4.03
Time frame: 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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