A Single-centre, Open, Single-dose, Self-control Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of SHR6390 in Healthy Chinese Adult Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Pharmacokinetics parameter: Cmax of SHR6390
研究概览
简要总结
The primary objective of the study is to evaluate the effect of itraconazole on pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR6390 tablets. The secondary objective of the study is to evaluate the safety of SHR6390 alone and when co-administered with itraconazole. The exploratory objective of the study is to explore the effect of SHR6390 related metabolic enzymes and transporter gene polymorphisms on the pharmacokinetics of SHR6390.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
- •Ability to complete the study as required by the protocol;
- •Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
- •Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 ~ 26 kg /m2 (including 19 and 26);
排除标准
- •Allergic constitution;
- •History of drug use, or drug abuse screening positive;
- •Alcoholic or often drinkers;
- •Left ventricular ejection fraction (LVEF) <50% by echocardiography;
- •A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
- •Abnormal clinical laboratory tests and clinical significance judged by the investigator or other clinical findings showing the following diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases.
研究组 & 干预措施
Treatment
subjects receiving a single oral dose of SHR6390 tablets, then itraconazole capsules 200 mg/day orally with a single oral dose of SHR6390 tablets co-administered.
干预措施: SHR6390 tablet (Drug)
Treatment
subjects receiving a single oral dose of SHR6390 tablets, then itraconazole capsules 200 mg/day orally with a single oral dose of SHR6390 tablets co-administered.
干预措施: Itraconazole capsule (Drug)
结局指标
主要结局
Pharmacokinetics parameter: Cmax of SHR6390
时间窗: through study completion, an average of 32 days
Peak Plasma Concentration (Cmax) of SHR6390
Pharmacokinetics parameter: AUC of SHR6390
时间窗: through study completion, an average of 32 days
Area under the plasma concentration versus time curve (AUC) of SHR6390
次要结局
- Pharmacokinetics parameter: Tmax of SHR6390(through study completion, an average of 32 days)
- Pharmacokinetics parameter: T1/2 of SHR6390(through study completion, an average of 32 days)
- Pharmacokinetics parameter: CL/F of SHR6390(through study completion, an average of 32 days)