NCT05354336已完成1 期
A Randomized, Open-Label, Phase I Clinical Study on SHR6390 of Different Specifications After Process Modification in Healthy Chinese Volunteers
适应症
干预措施
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
- Area under the plasma concentration versus time curve (AUC)0-t
研究概览
简要总结
This study was to evaluate the pharmacokinetics and safety of SHR6390 at doses of 100 mg, 125 mg, and 150 mg after process modification in Chinese healthy volunteers. A single oral dose of SHR6390 was given to each group, including 100 mg, 125mg and 150mg of SHR6390.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Healthy Chinese male and female aged 18-45years with a minimum weight of 50 kg for male and 45 kg for female subjects and a body mass index (BMI) of 18-26 kg/m2 who provided written informed consent for participating in the study.
- •Without history of cardiovascular, hepatic, kidney, pulmonary, endocrine, gastrointestinal, neurological, or psychiatric disease.
- •No pregnancy plan during the trial or within 6 months after completion of the trial.
- •Voluntarily signed the informed consent form and strictly adherence to the study protocol.
排除标准
- •vital signs, physical examination, 12-lead electrocardiogram, and laboratory examination had results of clinical significance.
- •Hepatitis B and C, human immunodeficiency virus (HIV) and syphilis antibody positive;
- •Any history of allergy, alcohol and drug abuse;
- •blood donation, massive blood loss (≥400mL).
- •Participated in other clinical trials within three months. (6) Severe infection or surgery four weeks prior to screening;
- •use of any drug that inhibits or induces hepatic metabolizing enzymes four weeks prior to screening;
- •use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines and health care products fourteen days prior to screening;
- •A history of dysphagia, gastrointestinal ulcers, or any gastrointestinal disease that interferes with drug absorption.
研究组 & 干预措施
SHR6390（100mg）
Experimental
干预措施: SHR6390(100mg) (Drug)
SHR6390（125mg）
Experimental
干预措施: SHR6390(125mg) (Drug)
SHR6390（150mg）
Experimental
干预措施: SHR6390(150mg) (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC)0-t
时间窗: 12 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
Peak Plasma Concentration (Cmax)
时间窗: 12 days
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)0-∞
时间窗: 12 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
次要结局
- Incidence of abnormal blood pressure(22 days)
- Incidence of Treatment-Emergent Adverse Events(22 days)
- Incidence of abnormal temperature(22 days)
- Incidence of abnormal electrocardiogram waveform(22 days)
研究者
研究点 (1)
Loading locations...
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