Clinical trial NCT03536481: Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lung Cancer
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-05-24
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak plasma concentration(Cmax) of ensartinib(test product) after meal
timeFrame: 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
measure: Peak plasma concentration(Cmax) of ensartinib(test product) under fasted sate
timeFrame: 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
measure: Peak plasma concentration(Cmax) of ensartinib(reference product) after meal
timeFrame: 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
measure: Peak plasma concentration(Cmax) of ensartinib(reference product) under fasted sate
timeFrame: 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
measure: Area under the plasma concentration versus time curve(AUC) of ensartinib(test product) after meal
timeFrame: 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
measure: Area under the plasma concentration versus time curve(AUC) of ensartinib(test product) under fasted sate
timeFrame: 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
measure: Area under the plasma concentration versus time curve(AUC) of ensartinib(reference product) after meal
timeFrame: 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
measure: Area under the plasma concentration versus time curve(AUC) of ensartinib(reference product) under fasted sate
timeFrame: 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 outcomes:
measure: Percentage of participants with adverse events as assessed by CTCAE v4.03
timeFrame: from screening to post-study visit, assessed up to 28 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
Study officials:
affiliation: Shanghai Public Health Clinical Center
name: Tongyu Zhu
role: PRINCIPAL_INVESTIGATOR
References: