In-Vivo Assessment of Silver Biomaterial Nano-Toxicity 32 Ppm
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change Sodium Blood Levels
研究概览
简要总结
The investigators propose to study oral commercial silver nanoparticle products on human enzyme activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-80 years old without debilitating chronic disease or history of cardiovascular event.
排除标准
- •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.
研究组 & 干预措施
32ppm Oral Silver
14 Days Active Silver Solution
干预措施: 32ppm Silver Particle (Drug)
Sterile Water
No Silver Nanoparticles
干预措施: Placebo (Drug)
结局指标
主要结局
Change Sodium Blood Levels
时间窗: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change in Chloride Blood Levels
时间窗: 14 days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Creatinine Blood Levels
时间窗: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Alanine Aminotransferase Blood Level
时间窗: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change in Total Protein Blood Levels
时间窗: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Total Bilirubin Blood Levels
时间窗: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Albumin Blood Levels
时间窗: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Calcium Blood Level
时间窗: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In White Blood Count Blood Levels
时间窗: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Red Blood Count Blood Levels
时间窗: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Hemoglobin Blood Levels
时间窗: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Hematocrit Blood Levels
时间窗: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Mean Corpuscular Volume Blood Levels
时间窗: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Mean Corpuscular Hemoglobin Concentration Blood Levels
时间窗: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Platelet Blood Levels
时间窗: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Granulocytes Blood Levels
时间窗: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Lymphocytes Blood Levels
时间窗: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Monocytes Blood Levels
时间窗: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Basophils Blood Levels
时间窗: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Eosinophils Blood Levels
时间窗: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Cytochrome P450 Assay on Dextromethorphan in Participants
时间窗: 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.
Cytochrome P450 Assay on Losartan in Participants
时间窗: 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.
Cytochrome P450 Assay on Caffeine in Participants
时间窗: 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.
Cytochrome P450 Assay on Omeprazole in Participants
时间窗: 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.
Cytochrome P450 Assay on Midazolam in Participants
时间窗: 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.
Change Potassium Blood Levels
时间窗: 14 days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change in Carbon Dioxide Blood Levels
时间窗: 14 days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Glucose Blood Levels
时间窗: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Alkaline Phosphatase Blood Level
时间窗: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Aspartate Aminotransferase Blood Level
时间窗: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Urea Nitrogen Blood Levels
时间窗: 14 days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
次要结局
- Total Change in Diastolic Blood Pressure Silver Participants(Baseline and 14 Days)
- Cytochrome P450 Assay on Chlorozoxazone in Participants Dosed With Silver(14 Days)
- Total Change in Systolic Blood Pressure Silver Participants(Baseline and 14 Days)
- Total Change in Heart Rate in Silver Participants(Baseline and 14 Days)