Status:
COMPLETED
Bioequivalency Study of CM082 Tablet in 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 bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers.
Detailed Description
The main objective of this study is to evaluate the bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers under fasted state or after meal. In addition, the safety of single...
Eligibility Criteria
Inclusion
- 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
- 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
- Intolerant of venipuncture, history of fainting needle and blood
- Lactose intolerant
- Drug abusing in 3 months
- Donated ≥200 mL of blood within 3 months before screening
- Pregnant or under lactation period (female subjects)
- Received any prescription drug, over-the-counter drug, prescription drug and Chinese herbal drug in 2 weeks, with the exception of vitamins and acetaminophen
- 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
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2020
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04328506
Start Date
June 1 2020
End Date
July 27 2020
Last Update
November 26 2021
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