Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers

• Status: Completed
• Trial end date: 2019-01-09
• Target enrollment: 0
• Participant gender: All

Summary

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

• 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:

• 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