Lung Cancer
Conditions
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.
Interventions
DRUGensartinib capsules (test product)
Test product(T)：100mg ensartinib capsules manufactured by Betta Pharmaceuticals
DRUGensartinib capsules (reference product)
Reference product(R)：100mg ensartinib capsules manufactured by Catalent Pharma Solutions
Sponsors
Betta Pharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) 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 |
| 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 |
| 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 |
Secondary
| Measure | 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 |
Countries
China
Outcome results
None listed