NCT02191787已完成1 期
Pharmacokinetic-pharmacodynamic Assessment of Seresis® o.d.: an Open, Uncontrolled, Non-randomised Intraindividual Pilot-study
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Changes in total antioxidant activity of Seresis®
研究概览
简要总结
Study to determine the antioxidant potency of Seresis® in the serum of healthy volunteers and the optimal time for blood sampling
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subjects to be enrolled are healthy volunteers, defined as follows:
- •Healthy men or women between 18 and 30 years old
- •Non-smokers
- •Fit for work
- •Having given informed consent and signed the form
排除标准
- •Any serious disorder that might interfere with his/her participation in this study and the evaluation of the safety of the test drug (e.g. renal insufficiency, hepatic dysfunction, cardiovascular disease, hypervitaminosis A, psychic disorder etc.).
- •Treatment with other drug that might interfere with the evaluation of the safety of the test drug
- •Known hypersensitivity to any of the ingredients of the study drug
- •Pregnancy, lactation, women of childbearing potential who do not use an established contraceptive
- •Drug and alcohol abuse
- •Participation in another trial
- •Known abnormal values of the laboratory tests (if detected after enrolment, subjects will continue the treatment provided there are not medical objections)
- •Specific dietary requirements that do not allow the volunteers to meet the dietary guidelines set out for this study
研究组 & 干预措施
Seresis® + Placebo
Experimental
2 capsules Seresis® o.d. for 5 days
2 capsules Placebo o.d. the day before treatment with Seresis®
干预措施: Seresis® (Drug)
Seresis® + Placebo
Experimental
2 capsules Seresis® o.d. for 5 days
2 capsules Placebo o.d. the day before treatment with Seresis®
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in total antioxidant activity of Seresis®
时间窗: Baseline, Day 2
determined by chemoluminescence
次要结局
- Assessment of tolerability on a 4-point scale(Day 14)
- Number of patients with abnormal changes in laboratory parameters(up to day 14)
- Number of patients with adverse events(up to day 14)
- Changes in total antioxidant activity of Seresis®(Day 2, day 6)
研究者
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