A Single-centre, Single-arm, Open-label and Fixed-sequence Drug-drug Interaction Study to Evaluate the Effect of Efavirenz on the Pharmacokinetics of SHR2150 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12月13日最近更新: 2021年12月20日

适应症

干预措施

试验速览

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

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-centre, open-label, fixed-sequence, self-controlled clinical trial. It is planned to enroll 20 healthy adult subjects.

Subjects will take SHR2150 on Day 1 and Day 21, and take efavirenz from Day 7 to Day 26.

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 the boundary value), male and female;
•Male body weight ≥ 50 kg, female body weight ≥ 45 kg, body mass index (BMI) within the range of 18 ~ 26 kg/m2 (including the boundary value) (BMI= weight (kg)/height 2 (m2));
•The physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, abdominal B-ultrasound, and chest radiograph are normal or have no clinical significance;
•The subjects with reproduction ability must agree to take effective contraceptive measures after signing the informed consent form and within 7 months (for female) or 4 months (for male) until the last 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 3 months before the trial, or plan to perform surgery during the study period;
•Those whose 12-lead ECG is abnormal with clinically significant or ECG QT interval (QTcF) ≥ 450 ms (for male) or > 460 ms (for female) or < 300 ms;
•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 or hard drugs; or 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 1 month 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 3 months before the test, that is, drinking more than 15 g of alcohol per day (15 g alcohol = 450 mL of beer, or 50 mL of spirits, or 150 mL of wine), and any alcohol-containing products cannot be stopped during the study;
•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;
•Women with pregnancy or within lactation period.

研究组 & 干预措施

Treatment group

Experimental

SHR2150+ efavirenz

干预措施: SHR2150 tablet、efavirenz (Drug)