NCT01469910已完成1 期
Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of Simotinib Hydrochloride 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
- 63
- 试验地点
- 1
- 主要终点
- The incidence and severity of adverse events
研究概览
简要总结
The purpose of this study is to assess the safety and pharmacokinetics of single ascending doses of Simotinib Hydrochloride in healthy subjects.
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 , male or female subjects
- •Age of 18 to 45 years
- •Body Mass Index (BMI) of 19 to 24 kg/m2; and a total body weight > 50 kg for male, > 45 kg for female
- •Written informed consent signed and dated by the subject
- •Subjects who are willing and able to comply with study procedures
排除标准
- •Any clinically significant disease or surgery within 4 weeks prior to the beginning of the study
- •Known hypersensitivity to the study drug or similar drugs
- •History of any serious disease, including but not limited to circulatory system, endocrine system, central nervous system, hematology, immunology, metabolic diseases and psychiatric disorders
- •History of gastrointestinal, hepatic, and renal diseases, affecting drug absorption and metabolism
- •Any clinically significant abnormal clinical laboratory tests
- •Abnormal ECG or vital signs
- •A positive test for HIV antibody
- •A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result
- •History of alcohol consumption within six months of the study defined as: an average weekly intake of > 14 units
- •History of regular tobacco use or nicotine containing products within three months prior to screening
- •Consumption of too much tea or coffee (> 8 cups/day)
- •Use of any drug, which inhibits or induces hepatic drug metabolism, within 30 days prior to the beginning of the study
- •Use of any drug within 14 days prior to the beginning of the study
- •Participate in other clinical trials within 30 days prior to the beginning of the study
- •Blood donation within 30 days of dosing
- •All female subjects must not be of child-bearing potential
- •Pregnant or lactating women
研究组 & 干预措施
Simotinib
Experimental
干预措施: Simotinib Hydrochloride (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The incidence and severity of adverse events
时间窗: within 7 days following administration of study drug
次要结局
- The maximum plasma concentration (Cmax)(0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 16h, 24 h, 36 h, 48 h)
- The time to Cmax (tmax)(0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 16h, 24 h, 36 h, 48 h)
- Area under the plasma concentration-time curve (AUC)(0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 16h, 24 h, 36 h, 48 h)
- The Terminal half-life (t1/2)(0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 16h, 24 h, 36 h, 48 h)
研究者
研究点 (1)
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