In-Vivo Assessment of Silver Biomaterial Nano-Toxicity 32 Ppm
2016年5月25日 更新者：mark munger、University of Utah
The investigators propose to study oral commercial silver nanoparticle products on human enzyme activity.
研究概览
研究类型
介入性
注册 (实际的)
12
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Utah
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Salt Lake City、Utah、美国、84112-5820
- University of Utah
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 18-80 years old without debilitating chronic disease or history of cardiovascular event.
Exclusion Criteria:
- Women physically capable of becoming pregnant, who are not using 2 barrier methods of birth control;
- Any female who is nursing;
- History of heavy metal allergy;
- History of asthma or Chronic Obstructive Pulmonary Disease;
- History of renal impairment;
- Symptoms of active upper respiratory disease at time of consent;
- Smoking more than 5 cigarettes or equivalent and not able to stop for 48 hours;
- Ability to discontinue chronic medications or nutraceuticals for 20 days or 5 half-lives of the agent, whichever is longer.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 分配：非随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：32ppm Oral Silver
14 Days Active Silver Solution
|
Oral silver dose of 32ppm
|
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安慰剂比较：Sterile Water
No Silver Nanoparticles
|
Sterile Water No Silver
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change Sodium Blood Levels
大体时间：14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change Potassium Blood Levels
大体时间：14 days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 days
|
|
Change in Chloride Blood Levels
大体时间：14 days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 days
|
|
Change in Carbon Dioxide Blood Levels
大体时间：14 days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 days
|
|
Change In Urea Nitrogen Blood Levels
大体时间：14 days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 days
|
|
Change In Creatinine Blood Levels
大体时间：14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Glucose Blood Levels
大体时间：14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Alkaline Phosphatase Blood Level
大体时间：14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Aspartate Aminotransferase Blood Level
大体时间：14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Alanine Aminotransferase Blood Level
大体时间：14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change in Total Protein Blood Levels
大体时间：14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Total Bilirubin Blood Levels
大体时间：14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Albumin Blood Levels
大体时间：14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Calcium Blood Level
大体时间：14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In White Blood Count Blood Levels
大体时间：14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Red Blood Count Blood Levels
大体时间：14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Hemoglobin Blood Levels
大体时间：14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Hematocrit Blood Levels
大体时间：14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Mean Corpuscular Volume Blood Levels
大体时间：14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Mean Corpuscular Hemoglobin Concentration Blood Levels
大体时间：14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Platelet Blood Levels
大体时间：14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Granulocytes Blood Levels
大体时间：14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Lymphocytes Blood Levels
大体时间：14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Monocytes Blood Levels
大体时间：14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Basophils Blood Levels
大体时间：14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Eosinophils Blood Levels
大体时间：14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Cytochrome P450 Assay on Dextromethorphan in Participants
大体时间：14 Days
|
Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days).
Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized.
The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.
|
14 Days
|
|
Cytochrome P450 Assay on Losartan in Participants
大体时间：14 Days
|
Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days).
Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized.
The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.
|
14 Days
|
|
Cytochrome P450 Assay on Caffeine in Participants
大体时间：14 Days
|
Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days).
Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized.
The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.
|
14 Days
|
|
Cytochrome P450 Assay on Omeprazole in Participants
大体时间：14 Days
|
Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days).
Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized.
The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.
|
14 Days
|
|
Cytochrome P450 Assay on Midazolam in Participants
大体时间：14 Days
|
Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days).
Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized.
The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.
|
14 Days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cytochrome P450 Assay on Chlorozoxazone in Participants Dosed With Silver
大体时间：14 Days
|
Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days).
Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized.
The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.
|
14 Days
|
|
Total Change in Systolic Blood Pressure Silver Participants
大体时间：Baseline and 14 Days
|
Assessment only completed on the 32ppm Oral Silver part of the trail
|
Baseline and 14 Days
|
|
Total Change in Diastolic Blood Pressure Silver Participants
大体时间：Baseline and 14 Days
|
Assessment only completed on the 32ppm Oral Silver part of the trail
|
Baseline and 14 Days
|
|
Total Change in Heart Rate in Silver Participants
大体时间：Baseline and 14 Days
|
Assessment only completed on the 32ppm Oral Silver part of the trail
|
Baseline and 14 Days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Mark Munger, Pharm.D.、University of Utah
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年7月1日
初级完成 (实际的)
2011年11月1日
研究完成 (实际的)
2011年11月1日
研究注册日期
首次提交
2011年7月19日
首先提交符合 QC 标准的
2011年7月28日
首次发布 (估计)
2011年7月29日
研究记录更新
最后更新发布 (估计)
2016年7月4日
上次提交的符合 QC 标准的更新
2016年5月25日
最后验证
2015年9月1日
更多信息
与本研究相关的术语
其他研究编号
- 50310 (MSD Sharp&Dohme GmbH)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
32ppm Silver Particle的临床试验
-
Trak Health Solutions S.L.University of the Basque Country (UPV/EHU); Basque Health Service完全的
-
University of ÉvoraUniversitätsklinikum Hamburg-Eppendorf招聘中
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Texas A & M University Baylor College Of DentistryUniversity of Washington尚未招聘