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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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.
The 1st Phase Clinical Research Center of the Second Affiliated Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, China
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Percentage of adverse events
Percentage of adverse events as assessed by CTCAE v4.0
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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