Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers

Study Overview
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Brief Summary
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The main objective of this study is to evaluate the bioequivalency of two preparations of ensartinib capsules in Chinese healthy volunteers.

Detailed Description
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The main objective of this study is to evaluate the bioequivalency of two preparations of ensartinib capsules in Chinese healthy volunteers under fasted state or after meal. In addition, the safety of single dose administration of ensartinib capsules in Chinese healthy volunteers will also be evaluated.

Official Title
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Randomized,Open Label,Two-cycle,Crossover,Single Dose Bioequivalency Study of Two Preparations of Ensartinib Capsules in Healthy Chinese Volunteers Under Fasted State and After Meal

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: ensartinib capsules (test product)
* Drug: ensartinib capsules (reference product)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male body weight≥50.0kg or female body weight≥45.0kg; BMI between 19.0-26.0 kg/m2(inclusive) Generally in good health, with no history of chronic disease or sever disease No (clinical significant) abnormal findings in clinical laboratory tests and physical examinations No plan for pregnancy in coming 6 months, and must practice effective contraception; No plan for sperm or egg donation Written informed consent Exclusion Criteria: History of food or drug allergies Clinical significant disease or disorders Received surgery in 3 months before screening, or have plan for surgery during the study Participated in other clinical trials within 3 months before screening Venipuncture intolerance Drug abusing in 6 months Donated ≥200 mL of blood within 30 days before screening Pregnant or under lactation period (female subjects) Received any prescription drug, over-the-counter drug, Chinese herbal drug or vitamins in 2 weeks Received any vaccine in 4 weeks Excessively smoking, alcohol or coffin-containing beverage drinking in 3 months Other circumstances that is deemed not appropriate for the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T-R cohort under fasted state<br>Subjects will be administered with one single dose of ensartinib capsules (test product) under fasted state, after a wash period of 14 days,the subjects will be administered with one single dose of ensartinib capsules (reference product) under fasted state. | Drug: ensartinib capsules (test product)<br>* Test product(T)：100mg ensartinib capsules manufactured by Betta Pharmaceuticals<br>* Other names: X-396 capsules;Drug: ensartinib capsules (reference product)<br>* Reference product(R)：100mg ensartinib capsules manufactured by Catalent Pharma Solutions<br>* Other names: X-396 capsules;|
| Experimental: R-T cohort under fasted state<br>Subjects will be administered with one single dose of ensartinib capsules (reference product) under fasted state, after a wash period of 14 days,the subjects will be administered with one single dose of ensartinib capsules (test product) under fasted state. | Drug: ensartinib capsules (test product)<br>* Test product(T)：100mg ensartinib capsules manufactured by Betta Pharmaceuticals<br>* Other names: X-396 capsules;Drug: ensartinib capsules (reference product)<br>* Reference product(R)：100mg ensartinib capsules manufactured by Catalent Pharma Solutions<br>* Other names: X-396 capsules;|
| Experimental: T-R cohort after meal<br>Subjects will be administered with one single dose of ensartinib capsules (test product) after meal, after a wash period of 14 days,the subjects will be administered with one single dose of ensartinib capsules (reference product) after meal. | Drug: ensartinib capsules (test product)<br>* Test product(T)：100mg ensartinib capsules manufactured by Betta Pharmaceuticals<br>* Other names: X-396 capsules;Drug: ensartinib capsules (reference product)<br>* Reference product(R)：100mg ensartinib capsules manufactured by Catalent Pharma Solutions<br>* Other names: X-396 capsules;|
| Experimental: R-T cohort after meal<br>Subjects will be administered with one single dose of ensartinib capsules (reference product) after meal, after a wash period of 14 days,the subjects will be administered with one single dose of ensartinib capsules (test product) after meal. | Drug: ensartinib capsules (test product)<br>* Test product(T)：100mg ensartinib capsules manufactured by Betta Pharmaceuticals<br>* Other names: X-396 capsules;Drug: ensartinib capsules (reference product)<br>* Reference product(R)：100mg ensartinib capsules manufactured by Catalent Pharma Solutions<br>* Other names: X-396 capsules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma concentration(Cmax) of ensartinib(test product) after meal | The Cmax of ensartinib(test product) in after meal blood samples of each subject over a 120 hour period post dose | pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour | 
| Peak plasma concentration(Cmax) of ensartinib(test product) under fasted sate | The Cmax of ensartinib(test product) in fasting blood samples of each subject over a 120 hour period post dose | pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour | 
| Peak plasma concentration(Cmax) of ensartinib(reference product) after meal | The Cmax of ensartinib(reference product) in after meal blood samples of each subject over a 120 hour period post dose | pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour | 
| Peak plasma concentration(Cmax) of ensartinib(reference product) under fasted sate | The Cmax of ensartinib(reference product) in fasting blood samples of each subject over a 120 hour period post dose | pre-dose(60minute),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(test product) after meal | The AUC of ensartinib(test product) in after meal blood samples of each subject over a 120 hour period post dose | pre-dose(60minute),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(test product) under fasted sate | The AUC of ensartinib(test product) in fasting blood samples of each subject over a 120 hour period post dose | pre-dose(60minute),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(reference product) after meal | The AUC of ensartinib(reference product) in after meal blood samples of each subject over a 120 hour period post dose | pre-dose(60minute),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(reference product) under fasted sate | The AUC of ensartinib(reference product) in fasting blood samples of each subject over a 120 hour period post dose | pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with adverse events as assessed by CTCAE v4.03 |  | from screening to post-study visit, assessed up to 28 days |