A Single-centre, Single-dose, Open-label and Self-control Study to Evaluate the Effect of Efavirenz on Pharmacokinetic of SHR6390 in Healthy Chinese Subjects

Jiangsu HengRui Medicine Co., Ltd.1 个研究点分布在 1 个国家目标入组 20 人开始时间: 2021年9月1日最近更新: 2021年11月29日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Jiangsu HengRui Medicine Co., Ltd.
入组人数: 20
试验地点: 1
主要终点: Cmax

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study is a single-center, open, single-dose, self-controlled clinical trial. It is planned to enroll 20 healthy adult subjects.Subjects will take the SHR6390 on Day1 and Day22 , and from Day8 to Day26 take the efavirenz.

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

•The subject can communicate well with the researcher, understand and comply with the requirements of this study, and understand and sign the informed consent;
•Healthy subjects aged 18~45 (including 18 and 45 years old);
•Male body weight ≥ 50kg, female body weight ≥ 45kg, body mass index (BMI) within the range of 19 ~ 26kg /m2 (including 19 and 26 kg/m2) (BMI= weight (kg)/height 2 (m2));
•The subjects had no fertility plan, took effective contraceptive measures voluntarily, and could not donate sperm or eggs within 7 months after signing the informed consent form to the last medication; the serum HCG test of women with fertility must be negative before the study medication.

排除标准

•Anyone who has suffered from any clinical serious disease such as the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities, or any other disease which can affect the study results.
•Those who have undergone surgery within 6 months before the trial, or plan to perform surgery during the study period;
•Those who donated blood or suffered heavy blood loss (≥400 mL), received blood transfusions, or used blood products within 3 months before enrollment;
•Have a history of allergies to drugs, food or other substances;
•Those who have used soft drugs (such as marijuana) within 3 months before the test or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the test; Those with positive results in urine drug abuse screening;
•Those who have participated in any clinical trials and have taken study drugs within 3 months before the first administration;
•Those who have taken any medicine within 4 weeks before the first administration (including prescription medicines, non-prescription medicines, Chinese herbal medicines, vitamins, calcium tablets and other food supplements), especially the drugs which have any effect on CYP3A4;
•Regular drinkers within 6 months before the test, that is, drinking more than 14 units of alcohol per week (1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine), and any alcohol-containing products cannot be stopped during the study Those who are positive for alcohol breath test;
•Those with any abnormal result (clinically significant) of vital signs, physical examination, 12-lead electrocardiogram, chest radiograph, abdominal ultrasound, colour Doppler echocardiography, hematology, clinical chemistry, urinalysis and coagulation;
•Hepatitis B virus surface antigen is positive, or hepatitis C virus antibody is positive, or treponema pallidum antibody is positive, or human immunodeficiency virus antibody is positive.

研究组 & 干预措施

Treatment group

Experimental

干预措施: SHR6390、efavirenz (Drug)