NCT02114957已完成早期 1 期
Single Oral Dose Pharmacokinetics of Decursin/Decursinol Angelate in Healthy Adult Men and Women
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Area under the plasma concentration versus time curve (AUC) of decursin, decursinol angelate (DA) and decursinol
研究概览
简要总结
This study is to investigate how human bodies absorb and metabolize two herbal drugs. The information is critical for drug development and could not be obtained from any other studies using animals. The two herbal drugs are decursin and decursinol angelate (DA) which naturally exist in a traditional herb Angelica gigas Nakai (AGN). Preclinical and clinical studies indicated that AGN and decursin/DA were quite safe to animals and human.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Health subjects weighing between 50 to 91 kilograms (110 to 200 pounds)
- •Subjects 18 to 65 years of age
- •Subjects having normal hepatic, renal and bone marrow function as assessed by history, physical and clinical chemistry analysis
排除标准
- •Subjects positive for HIV, HBV and HCV
- •Subjects with diabetes-due to length of fasting
- •Subjects regularly taking any kind of prescription medications
- •Subjects taking oral contraception, hormone-containing IUDs, contraception implants, or Depo medroxyprogesterone injections
- •Subjects taking any food or herbal supplements containing AGN (e.g. CognIQTM, D-Cursinol, Decursinol-50™, Ache Action™, Fast-Acting Joint Formula, EstroG-100™) within 30 days of the study.
- •Female subjects that are pregnant, <6 months postpartum, or breastfeeding women.
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC) of decursin, decursinol angelate (DA) and decursinol
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 , 24, 48 hours post-dose
次要结局
- vital signs, plasma biochemistry and blood cell counts of subjects after consumption the study herb(0 and 24 hours post-dose)
研究者
研究点 (2)
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