Clinical trial NCT04328506: Bioequivalency Study of CM082 Tablet in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Malignant Solid Tumors
Lead sponsor: AnewPharma
Sponsor class: INDUSTRY
First posted: 2020-03-31
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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
* 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

Primary outcomes:
measure: Peak plasma concentration(Cmax) of CM082 (test product or reference product) under fasted state or after meal
timeFrame: 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]
measure: Area under the plasma concentration versus time curve(AUC) of CM082 (test product or reference product) under fasted state or after meal
timeFrame: 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]
measure: Time of maximum concentration (Tmax) of CM082 (test product or reference product) under fasted state or after meal
timeFrame: 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 outcomes:
measure: Percentage of adverse events
timeFrame: From the first occurrence of adverse events after administration to the cessation of adverse events, assessed up to 2 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The 1st Phase Clinical Research Center of the Second Affiliated Hospital of Zhejiang University Medical College
state: Zhejiang
Study officials:
affiliation: the Second Affiliated Hospital of Zhejiang University Medical College
name: zourong ruan
role: STUDY_CHAIR
References: