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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve(AUC) of CM082 (test product or reference product) under fasted state or after meal
研究概览
简要总结
The main objective of this study is to evaluate the bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
R-T cohort under fasted state
Subjects will be administered with one single dose of CM082 tablet (reference product) under fasted state, after a wash period of 5 days,the subjects will be administered with one single dose of CM082 tablet (test product) under fasted state.
干预措施: CM082 tablet (reference product) (Drug)
T-R cohort under fasted state
Subjects will be administered with one single dose of CM082 tablet (test product) under fasted state, after a wash period of 5 days, the subjects will be administered with one single dose of CM082 tablet (reference product) under fasted state.
干预措施: CM082 tablet (test product) (Drug)
T-R cohort after meal
Subjects will be administered with one single dose of CM082 tablet (test product) after meal, after a wash period of 5 days,the subjects will be administered with one single dose of CM082 tablet (reference product) after meal.
干预措施: CM082 tablet (reference product) (Drug)
R-T cohort after meal
Subjects will be administered with one single dose of CM082 tablet (reference product) after meal, after a wash period of 14 days,the subjects will be administered with one single dose of CM082 tablet (test product) after meal
干预措施: CM082 tablet (test product) (Drug)
T-R cohort under fasted state
Subjects will be administered with one single dose of CM082 tablet (test product) under fasted state, after a wash period of 5 days, the subjects will be administered with one single dose of CM082 tablet (reference product) under fasted state.
干预措施: CM082 tablet (reference product) (Drug)
R-T cohort after meal
Subjects will be administered with one single dose of CM082 tablet (reference product) after meal, after a wash period of 14 days,the subjects will be administered with one single dose of CM082 tablet (test product) after meal
干预措施: CM082 tablet (reference product) (Drug)
R-T cohort under fasted state
Subjects will be administered with one single dose of CM082 tablet (reference product) under fasted state, after a wash period of 5 days,the subjects will be administered with one single dose of CM082 tablet (test product) under fasted state.
干预措施: CM082 tablet (test product) (Drug)
T-R cohort after meal
Subjects will be administered with one single dose of CM082 tablet (test product) after meal, after a wash period of 5 days,the subjects will be administered with one single dose of CM082 tablet (reference product) after meal.
干预措施: CM082 tablet (test product) (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve(AUC) of CM082 (test product or reference product) under fasted state or after meal
时间窗: 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
Peak plasma concentration(Cmax) of CM082 (test product or reference product) under fasted state or after meal
时间窗: 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
Time of maximum concentration (Tmax) of CM082 (test product or reference product) under fasted state or after meal
时间窗: 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
次要结局
- Percentage of adverse events(From the first occurrence of adverse events after administration to the cessation of adverse events, assessed up to 2 months)