Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers

Betta Pharmaceuticals Co., Ltd.74 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

ensartinib capsules (test product)DRUG

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

ensartinib capsules (reference product)DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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