NCT02181959已完成2 期
Safety and Tolerability of PHARMATON Capsules vs PHARMATON Capsules With DMAE vs Placebo in Healthy Volunteers (A Double-blind, Controlled Multicentre Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 138
- 主要终点
- Number of patients with adverse events
研究概览
简要总结
The purpose of this trial was to evaluate the safety and tolerability of a galenic formulation of Pharmaton® capsules containing 2-Dimethylaminoethanol (DMAE) in healthy volunteers.
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
- Double
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy man or woman, between 20 to 70 years
- •Fit to work
- •Volunteers have given informed consent and signed the consent 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, disorders of the calcium metabolism, hypervitaminosis A or D, psychic disorder, etc)
- •Treatment with other drugs that might interfere with the evaluation of the safety of the test drug
- •Known hypersensitivity to any 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 no medical objections)
研究组 & 干预措施
Pharmaton® with DMAE
Experimental
干预措施: Pharmaton® with DMAE (Drug)
Pharmaton® without DMAE
Active Comparator
干预措施: Pharmaton® without DMAE (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of patients with adverse events
时间窗: up to 60 days
Assessment of overall tolerability rate on a 4-point scale
时间窗: Day 30 and 60
次要结局
- Number of patients with abnormal changes in laboratory parameters(Day 0, 30 and 60)
- Number of patients with abnormal findings in physical examination(Day 0, 30 and 60)
研究者
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