NCT02431832已完成1 期
Exploration of microRNA and Metabolomics Biomarkers Predicting Drug Induced Liver Injury in Elderly People
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
- 17
- 试验地点
- 1
- 主要终点
- Area Under Curve (AUC)
研究概览
简要总结
An open-label, one-sequence, multiple administration study for exploration of microRNA and metabolomics biomarkers to predict drug induced liver injury in healthy elderly Korean people.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 84 Years（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects, as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations were eligible to participate in the study. Subjects had to be 65 to 84 years of age.
排除标准
- •Subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
- •Subject judged not eligible for study participation by investigator
研究组 & 干预措施
Augmentin tab
Experimental
干预措施: Augmentin tab (Drug)
结局指标
主要结局
Area Under Curve (AUC)
时间窗: up to 35 days
次要结局
未报告次要终点
研究者
Jae Yong Chung, MD, PhD
M.D., Ph.D
Seoul National University Bundang Hospital
研究点 (1)
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