A Study to Investigate the Food Effect on the Pharmacokinetics of Ensartinib Capsules in Chinese Healthy Volunteers.

• Status: Completed
• Trial end date: 2018-08-02
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of Ensartinib Capsules.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.; Betta Pharmaceuticals Co.,Ltd.
• Treatments: Ensartinib

Criteria

Inclusion Criteria:

• age: 20 - 45 years;

• sex: male and female;

• body weight: Male ≥ 50 kg,female ≥ 45 kg, body mass index BMI (weight (kg)/height 2 (m2)) between 19-26 kg/m2 (including border);

• Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and all lab tests;

• written informed consent;

Exclusion Criteria:

• Received any investigational drugs within 14 days before the screening test;

• Donated 200 mL of whole blood within 30 days before the screening test,or Donated 200 mL of whole blood during the study or within 30 days after completion of the study;

• Females who are lactating, pregnant, potentially child-bearing, or willing to get pregnant during the study period;

• History of drug or food allergies;

• Abnormal blood pressure or pulse，Abnormal laboratory tests;

• Participated in other clinical trials within 3 months before screening;

• Smoking and drinking within 3 months before screening or test results of smoke, alcohol, and drug abuse are positive;Positive for HBsAg, Hepatitis C virus (HCV) antibody, HIV antibody or syphilis antibody;Clinically apparent disease/infection within 1 month before screening;

• Positive for HBsAg, Hepatitis C virus (HCV) antibody, HIV antibody or syphilis antibody;

• Clinically apparent disease/infection within 1 month before screening;