Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers

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

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

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: ensartinib capsules (test product); Drug: ensartinib capsules (reference product)

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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201508
      • Shanghai Public Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T-R cohort under fasted state; 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); Test product(T)：100mg ensartinib capsules manufactured by Betta Pharmaceuticals; Other Names: X-396 capsules; Drug: ensartinib capsules (reference product); Reference product(R)：100mg ensartinib capsules manufactured by Catalent Pharma Solutions; Other Names: X-396 capsules
Experimental: R-T cohort under fasted state; 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); Test product(T)：100mg ensartinib capsules manufactured by Betta Pharmaceuticals; Other Names: X-396 capsules; Drug: ensartinib capsules (reference product); Reference product(R)：100mg ensartinib capsules manufactured by Catalent Pharma Solutions; Other Names: X-396 capsules
Experimental: T-R cohort after meal; 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); Test product(T)：100mg ensartinib capsules manufactured by Betta Pharmaceuticals; Other Names: X-396 capsules; Drug: ensartinib capsules (reference product); Reference product(R)：100mg ensartinib capsules manufactured by Catalent Pharma Solutions; Other Names: X-396 capsules
Experimental: R-T cohort after meal; 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); Test product(T)：100mg ensartinib capsules manufactured by Betta Pharmaceuticals; Other Names: X-396 capsules; Drug: ensartinib capsules (reference product); Reference product(R)：100mg ensartinib capsules manufactured by Catalent Pharma Solutions; Other Names: X-396 capsules

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Betta Pharmaceuticals Co., Ltd.
• Investigators: Principal Investigator: Tongyu Zhu, Shanghai Public Health Clinical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2018
• Primary Completion (Actual): January 9, 2019
• Study Completion (Actual): January 9, 2019

Study Registration Dates

• First Submitted: April 15, 2018
• First Submitted That Met QC Criteria: May 23, 2018
• First Posted (Actual): May 24, 2018

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Ensartinib
• Other Study ID Numbers: BTP-44315

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No