Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers

NCT ID: NCT03536481

Last Updated: 2019-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-11
• Study Completion Date: 2019-01-09

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ensartinib capsules (test product)

Intervention Type: DRUG

Test product(T)：100mg ensartinib capsules manufactured by Betta Pharmaceuticals

ensartinib capsules (reference product)

Intervention Type: DRUG

Reference product(R)：100mg ensartinib capsules manufactured by Catalent Pharma Solutions

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.

Group Type: EXPERIMENTAL

ensartinib capsules (test product)

Intervention Type: DRUG

Test product(T)：100mg ensartinib capsules manufactured by Betta Pharmaceuticals

ensartinib capsules (reference product)

Intervention Type: DRUG

Reference product(R)：100mg ensartinib capsules manufactured by Catalent Pharma Solutions

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.

Group Type: EXPERIMENTAL

ensartinib capsules (test product)

Intervention Type: DRUG

Test product(T)：100mg ensartinib capsules manufactured by Betta Pharmaceuticals

ensartinib capsules (reference product)

Intervention Type: DRUG

Reference product(R)：100mg ensartinib capsules manufactured by Catalent Pharma Solutions

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.

Group Type: EXPERIMENTAL

ensartinib capsules (test product)

Intervention Type: DRUG

Test product(T)：100mg ensartinib capsules manufactured by Betta Pharmaceuticals

ensartinib capsules (reference product)

Intervention Type: DRUG

Reference product(R)：100mg ensartinib capsules manufactured by Catalent Pharma Solutions

Interventions

ensartinib capsules (test product)

Test product(T)：100mg ensartinib capsules manufactured by Betta Pharmaceuticals

Intervention Type: DRUG

ensartinib capsules (reference product)

Reference product(R)：100mg ensartinib capsules manufactured by Catalent Pharma Solutions

Intervention Type: DRUG

Other Intervention Names

X-396 capsules; X-396 capsules

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Betta Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tongyu Zhu

Role: PRINCIPAL_INVESTIGATOR

Shanghai Public Health Clinical Center

Locations

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

BTP-44315

Identifier Type: -

Identifier Source: org_study_id