Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers
- Conditions
- Lung Cancer
- Interventions
- Registration Number
- NCT03536481
- Lead Sponsor
- Betta Pharmaceuticals Co., Ltd.
- Brief Summary
The main objective of this study is to evaluate the bioequivalency of two preparations of ensartinib capsules in Chinese healthy volunteers.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description T-R cohort under fasted state ensartinib capsules (test product) 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. R-T cohort under fasted state ensartinib capsules (test product) 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. T-R cohort after meal ensartinib capsules (reference product) 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. R-T cohort under fasted state ensartinib capsules (reference product) 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. R-T cohort after meal ensartinib capsules (test product) 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. T-R cohort under fasted state ensartinib capsules (reference product) 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. T-R cohort after meal ensartinib capsules (test product) 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. R-T cohort after meal ensartinib capsules (reference product) 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.
- Primary Outcome Measures
Name Time Method Peak plasma concentration(Cmax) of ensartinib(reference product) after meal 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 The Cmax of ensartinib(reference product) in after meal blood samples of each subject over a 120 hour period post dose
Area under the plasma concentration versus time curve(AUC) of ensartinib(reference product) under fasted sate 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 The AUC of ensartinib(reference product) in fasting blood samples of each subject over a 120 hour period post dose
Area under the plasma concentration versus time curve(AUC) of ensartinib(reference product) after meal 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 The AUC of ensartinib(reference product) in after meal blood samples of each subject over a 120 hour period post dose
Peak plasma concentration(Cmax) of ensartinib(test product) after meal 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 The Cmax of ensartinib(test product) in after meal blood samples of each subject over a 120 hour period post dose
Peak plasma concentration(Cmax) of ensartinib(test product) under fasted sate 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 The Cmax of ensartinib(test product) in fasting blood samples of each subject over a 120 hour period post dose
Peak plasma concentration(Cmax) of ensartinib(reference product) under fasted sate 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 The Cmax of ensartinib(reference product) in fasting blood samples of each subject over a 120 hour period post dose
Area under the plasma concentration versus time curve(AUC) of ensartinib(test product) after meal 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 The AUC of ensartinib(test product) in after meal blood samples of each subject over a 120 hour period post dose
Area under the plasma concentration versus time curve(AUC) of ensartinib(test product) under fasted sate 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 The AUC of ensartinib(test product) in fasting blood samples of each subject over a 120 hour period post dose
- Secondary Outcome Measures
Name Time Method Percentage of participants with adverse events as assessed by CTCAE v4.03 from screening to post-study visit, assessed up to 28 days
Trial Locations
- Locations (1)
Shanghai Public Health Clinical Center
🇨🇳Shanghai, Shanghai, China