NCT07040787已完成1 期
A Single-center, Single-arm, Fixed-sequence Drug-drug Interaction Study of HRS-5965 With Clopidogrel and Clarithromycin in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The maximum plasma concentration (Cmax)
研究概览
简要总结
The study is being conducted to compare the drug-drug interaction of HRS-5965 with clopidogrel and clarithromycin in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Ability to understand the study procedures and methods, participate voluntarily and be able to complete the study according to the protocol requirements, and sign the informed consent form (ICF) in writing.
- •Aged 18-45 years old on the date of signing the ICF (including the threshold), both male and female.
- •At the time of screening, male subjects weighing no less than 50 kg and female subjects weighing no less than 45 kg; body mass index (BMI): 19~26 kg/m2 (including the threshold).
- •During the screening period, human immunodeficiency virus antibody (HIV-Ab), treponema pallidum antibody, hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCV-Ab) were all negative.
- •Female subjects with reproductive capacity or male subjects whose partners are female subjects with reproductive capacity need to have no plans for fertility or sperm/egg donation within 3 months +1 week for male subjects and 6 months +1 week for female subjects from the date of signing the informed consent form until the last medication use, and voluntarily take efficient contraceptive measures (including partners).
排除标准
- •Allergic to two or more allergens, or in the judgment of the investigator, may be allergic to the study drug or its components.
- •Disease or medical condition that, in the judgment of the investigator, may interfere with the absorption, distribution, metabolism, and excretion of the drug or that may reduce compliance.
- •Patients with a previous history of coronary artery disease, severe cardiac insufficiency, conduction disorders or clinically significant bradycardia.
- •Patients with a history of electrolyte disorders (such as hypomagnesemia).
- •Patients with a history of congenital or acquired QT interval prolongation or ventricular arrhythmia.
- •Those with a history of meningococcal infection and streptococcus pneumoniae infection.
- •Those with a history of neuromuscular diseases (such as myotonic dystrophy, poliomyelitis, myasthenia gravis, botulism poisoning) and poliomyelitis.
- •Subjects who have had or are currently suffering from active pathological bleeding.
- •Subjects with a previous history of recurrent oral ulcers.
研究组 & 干预措施
Drug-drug interaction between HRS-5965 and clopidogrel
Experimental
干预措施: HRS-5965 Capsules (Drug)
Drug-drug interaction between HRS-5965 and clopidogrel
Experimental
干预措施: Clopidogrel (Drug)
Drug-drug interaction between HRS-5965 and clarithromycin
Experimental
干预措施: HRS-5965 Capsules (Drug)
Drug-drug interaction between HRS-5965 and clarithromycin
Experimental
干预措施: Clarithromycin (Drug)
结局指标
主要结局
The maximum plasma concentration (Cmax)
时间窗: Day 1 to day 12.
Area under the concentration curve from time 0 to the last quantifiable concentration (AUClast)
时间窗: Day 1 to day 12.
次要结局
- Time to maximum plasma concentration(Day 1 to day 12.)
- Terminal half-life (t1/2)(Day 1 to day 12.)
- Incidence and severity of adverse events (AEs)(Day 1 up to day 19.)
研究者
研究点 (1)
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