Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03536481
• Other study ID #: BTP-44315
• Status: Completed
• Phase: Phase 1
• Start date: June 11, 2018
• Est. completion date: January 9, 2019

Study information

• Verified date: July 2019
• Source: Betta Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: January 9, 2019
• Est. primary completion date: January 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Drug:
• ensartinib capsules (test product)
Test product(T):100mg ensartinib capsules manufactured by Betta Pharmaceuticals
• ensartinib capsules (reference product)
Reference product(R):100mg ensartinib capsules manufactured by Catalent Pharma Solutions

Locations

Country	Name	City	State
China	Shanghai Public Health Clinical Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Percentage of participants with adverse events as assessed by CTCAE v4.03		from screening to post-study visit, assessed up to 28 days