NCT06354556已完成1 期
Effect of Verapamil on the Pharmacokinetic of HRS-1893 Tablets in Healthy Subjects: a Single Center, Open, Single Arm, and Fixed Sequence Study
Shandong Suncadia Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2024年4月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Maximum observed serum concentration (Cmax) for HRS-1893 after Single dose
研究概览
简要总结
The purpose of this phase Ⅰ study is to evaluate the effect of oral verapamil tablets on the pharmacokinetics of HRS-1893 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF).
- •Male or female aged 18-55（adult healthy volunteers).
- •Body mass index (BMI) between 19 and 28 kg/m
- •Normal Electrocardiogram (ECG).
排除标准
- •History of persistent tachyarrhythmia and syncope.
- •A history of stomach or bowel surgery or excision.
- •Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.
- •Those who have participated in any clinical trials and have taken study drugs within 3 months before the first administration.
研究组 & 干预措施
Single arm
Experimental
干预措施: HRS-1893 tablet (Drug)
Single arm
Experimental
干预措施: Verapamil tablet (Drug)
结局指标
主要结局
Maximum observed serum concentration (Cmax) for HRS-1893 after Single dose
时间窗: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Area under the plasma concentration versus time curve from time zero to last measurable timepoint (AUC0-t) for HRS-1893 after single dose
时间窗: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Area under the plasma concentration versus time curve from time zero extrapolated to infinity (AUC0-inf) for HRS-1893 after single dose
时间窗: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
次要结局
- Time to maximum observed serum concentration (Tmax) for HRS-1893 after single dose(from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose)
- Elimination half-life (T1/2) for HRS-1893 after single dose(from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose)
- Apparent oral clearance (CL/F) for HRS-1893 after single dose(from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose)
- Apparent volume of distribution (Vz/F) for HRS-1893 after single dose(from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose)
- Accumulated amount of excretion (Ae) for HRS-1893 after single dose(from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose)
- Urinary excretion fraction（fe）for HRS-1893 after single dose(from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose)
- Renal clearance（CLr）for HRS-1893 after single dose(from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose)
- Number of subjects with adverse events and the severity of adverse events(from Day 1 to Day 24 after the first dose)
研究者
研究点 (1)
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