A Pharmacokinetic Study in Chinese Healthy Male and Female Volunteers to Investigate the Effect of Food on the Pharmacokinetics of Ensartinib Capsules.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUC) of Ensartinib
研究概览
简要总结
The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of Ensartinib Capsules.
详细描述
The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of Ensartinib Capsules in Chinese Healthy Volunteers. In addition, the safety of Ensartinib Capsules in Chinese Healthy Volunteers who with High-fat meal or fasting state 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
- •age: 20 - 45 years;
- •sex: male and female;
- •body weight: Male ≥ 50 kg,female ≥ 45 kg, body mass index BMI (weight (kg)/height 2 (m2)) between 19-26 kg/m2 (including border);
- •Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and all lab tests;
- •written informed consent;
排除标准
- •Received any investigational drugs within 14 days before the screening test;
- •Donated 200 mL of whole blood within 30 days before the screening test,or Donated 200 mL of whole blood during the study or within 30 days after completion of the study;
- •Females who are lactating, pregnant, potentially child-bearing, or willing to get pregnant during the study period;
- •History of drug or food allergies;
- •Abnormal blood pressure or pulse，Abnormal laboratory tests;
- •Participated in other clinical trials within 3 months before screening;
- •Smoking and drinking within 3 months before screening or test results of smoke, alcohol, and drug abuse are positive;Positive for HBsAg, Hepatitis C virus (HCV) antibody, HIV antibody or syphilis antibody;Clinically apparent disease/infection within 1 month before screening;
- •Positive for HBsAg, Hepatitis C virus (HCV) antibody, HIV antibody or syphilis antibody;
- •Clinically apparent disease/infection within 1 month before screening;
研究组 & 干预措施
Period 1: fed control → Period 2: fasted control
Period 1: administration of Ensartinib 225mg at 7:30am, 30 minutes after the breakfast；Period 2: administration of Ensartinib 225mg at 7:30am, without the breakfast
干预措施: Ensartinib with fed or fasting (Drug)
Period 1: fasted control → Period 2: fed control
Period 1: administration of Ensartinib 225mg at 7:30am, without the breakfast；Period 2: administration of Ensartinib 225mg at 7:30am, 30 minutes after the breakfast
干预措施: Ensartinib with fed or fasting (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC) of Ensartinib
时间窗: pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour
The effect of food on AUC after high fat diet and fasting Blood sampling over a 120 hour period post dose in all dosing sessions
Peak plasma concentration (Cmax) of Ensartinib
时间窗: pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour
The effect of food on Cmax after high fat diet and fasting Blood sampling over a 120 hour period post dose in all dosing sessions
Time of maximum concentration（Tmax）of Ensartinib
时间窗: pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour
The effect of food on Tmax after high fat diet and fasting Blood sampling over a 120 hour period post dose in all dosing sessions
Half life（T1/2）of Ensartinib
时间窗: pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour
The effect of food on T1/2 after high fat diet and fasting Blood sampling over a 120 hour period post dose in all dosing sessions
次要结局
- Percentage of adverse events(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 months)