Advanced Malignant Solid Tumors
Conditions
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 dose administration of CM082 tablet in Chinese healthy volunteers will also be evaluated.
Interventions
DRUGCM082 tablet (test product)
Test product(T)：100mg CM082 tablet manufactured by Betta Pharmaceuticals
DRUGCM082 tablet (reference product)
Reference product(R)：100mg CM082 tablet manufactured by Catalent Pharma Solutions
Sponsors
AnewPharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak plasma concentration(Cmax) of CM082 (test product or reference product) under fasted state or after meal | 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] | 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 |
| Area under the plasma concentration versus time curve(AUC) of CM082 (test product or reference product) under fasted state or after meal | 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] | 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 |
| Time of maximum concentration (Tmax) of CM082 (test product or reference product) under fasted state or after meal | 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] | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of adverse events | From the first occurrence of adverse events after administration to the cessation of adverse events, assessed up to 2 months | Percentage of adverse events as assessed by CTCAE v4.03 |
Countries
China
Outcome results
None listed