Advanced Malignant Solid Tumors Clinical Trial
Official title:
Randomized,Open Label,Two-cycle,Crossover,Single Dose Bioequivalency Study of Two Preparations of CM082 Tablet in Healthy Chinese Volunteers Under Fasted State and After Meal
Verified date | March 2020 |
Source | AnewPharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main objective of this study is to evaluate the bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers.
Status | Completed |
Enrollment | 96 |
Est. completion date | July 27, 2020 |
Est. primary completion date | July 27, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | 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 - 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 |
Country | Name | City | State |
---|---|---|---|
China | The 1st Phase Clinical Research Center of the Second Affiliated Hospital of Zhejiang University Medical College | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
AnewPharma |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peak plasma concentration(Cmax) of CM082 (test product or reference product) under fasted state or after meal | The Cmax ofCM082 (test product or reference product) in under fasted state or after meal blood samples of each subject over a 72 hour period post dose | pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,10,12,16,24,36,48,72 hour] | |
Primary | Area under the plasma concentration versus time curve(AUC) of CM082 (test product or reference product) under fasted state or after meal | The AUC of CM082 (test product or reference product) in under fasted state or after meal blood samples of each subject over a 72 hour period post dose | pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,10,12,16,24,36,48,72 hour] | |
Primary | Time of maximum concentration (Tmax) of CM082 (test product or reference product) under fasted state or after meal | The Tmax of CM082 (test product or reference product) in under fasted state or after meal blood samples of each subject over a 72 hour period post dose | pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,10,12,16,24,36,48,72 hour] | |
Secondary | Percentage of adverse events | Percentage of adverse events as assessed by CTCAE v4.03 | From the first occurrence of adverse events after administration to the cessation of adverse events, assessed up to 2 months |
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