Status:
COMPLETED
A Study to Investigate the Food Effect on the Pharmacokinetics of CM082 Tablet in Chinese Healthy Volunteers
Lead Sponsor:
AnewPharma
Conditions:
Advanced Malignant Solid Tumors
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of CM082 tablet.
Detailed Description
The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of CM082 tablet in Chinese Healthy Volunteers. In addition, the safety of CM082 tablet in Chinese Healthy Vol...
Eligibility Criteria
Inclusion
- age: 18 - 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;
- Abstinence or physical contraception approved by researchers must be approved during and within three months after the trial is completed; and no sperm and egg donation plan is available；
- Written informed consent;
Exclusion
- 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;
- The researchers determined that there were other conditions that were not suitable for the trial;
Key Trial Info
Start Date :
December 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04126668
Start Date
December 19 2019
End Date
January 16 2020
Last Update
May 21 2020
Active Locations (1)
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1
The 1st Phase Clinical Research Center of the Second Affiliated Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, China, 311009