A Study to Evaluate Pharmacokinetics of C3G and to Estimate Antioxidative Markers After Repeated Administration of Black Bean Seed Coat Extract
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Cmax - Maximum Observed Concentration - C3G in Plasma
研究概览
简要总结
This study is to evaluate pharmacokinetic-pharmacodynamic property of C3G after administration of Mulberry fruit extract to 12 healthy Korean volunteers. Plasma concentration of C3G and the antioxidative markers such as total antioxidative capacity and attack of free oxygen radical will be measured.
Additional objective is to investigate the multiple dose (2 weeks) safety of daily 1000mg black bean seed coat extract.
This study, as an exploratory trial, does not required statistical hypothesis
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body weight >55 kg for male, >45 kg for female (within 80-120% of Ideal body weight)
- •Give written informed consent and voluntarily decide participation
排除标准
- •Acute or chronic disease symptom on screening
- •Existing active and clinically significant disease involving more than one organ system
- •Known allergy to Mulberry or other berries
- •Positive drug or alcohol screening
- •Smokers of 10 or more cigarettes per day
- •Participation in a clinical trial during last 2 month prior to the start of the study
- •Pregnancy
结局指标
主要结局
Cmax - Maximum Observed Concentration - C3G in Plasma
时间窗: Blood samples collected over 6 hours
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - C3G in Plasma
时间窗: Blood samples collected over 6 hours
Antioxidative markers
时间窗: 2 weeks
次要结局
- Number of Participants with Adverse Events(for 4 weeks)