Pharmacokinetics of Advantage Arrest in Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Predicted Peak Serum Silver Concentration (Cmax)
研究概览
简要总结
The purpose of this study is to characterize basic PK parameters (Cmax, t1/2, AUC) in healthy children to contribute to evidence for the safety of Advantage Arrest, consistent with Guidance for Industry--Exposure--Response Relationships (April 2003).
详细描述
This is a topical agent where the active ingredients are applied to the teeth and eventually swallowed and may be absorbed through the GI tract or excreted. Minimal amounts are absorbed through the oral mucosa. Serum concentrations of silver and fluoride will be be proportional to the dose of silver and fluoride administered topically to the teeth as part of Advantage Arrest. This is an open label exposure-response study with up to 50 healthy children ages 3-13 years of age. Subjects will be treated with Advantage Arrest and have one blood sample withdrawn at a randomly assigned time point. A minimum of 3 subjects per time point at 2,4,6,24,48,96 and 168 hours. Serum samples will be analyzed for F and Ag.
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
- 3 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least one carious lesion.
排除标准
- •Oral mucositis
- •Any ulcerative lesions
- •Hypersensitivity to silver
- •Hypersensitivity to fluoride.
- •SDF treatment within 3 months.
研究组 & 干预措施
Advantage Arrest
38% silver diamine fluoride, topical, 1 drop, single application
干预措施: Silver Diamine Fluoride (Drug)
结局指标
主要结局
Predicted Peak Serum Silver Concentration (Cmax)
时间窗: Based on data collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application
As only a single blood sample was obtained from each child, serum silver concentration versus time data were analyzed simultaneously using population pharmacokinetic analysis with nonlinear mixed effects modeling. The parameters estimated were the apparent volume of distribution (V/F) and apparent oral clearance (CL/F). The rate constant of absorption (ka) was fixed to 23.7 day-1. The predicted peak serum silver Cmax was calculated using Cmax = Dose/(V/F)\*exp\^(-k⋅tmax ), where k = (CL/F)/(V/F) and tmax = \[ln(ka/k)\]/(ka-k).
Predicted Time to Peak Serum Silver Concentration (Tmax)
时间窗: Based on data collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application
As only a single blood sample was obtained from each child, serum silver concentration versus time data were analyzed simultaneously using population pharmacokinetic analysis with nonlinear mixed effects modeling. The parameters estimated were the apparent volume of distribution (V/F) and apparent oral clearance (CL/F). The rate constant of absorption (ka) was fixed to 23.7 day-1. The predicted time to peak concentration was calculated using tmax = \[ln(ka/k)\]/(ka-k), where k = (CL/F)/(V/F).
Silver Half-life
时间窗: Based on data collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application
As only a single blood sample was obtained from each child, serum silver concentration versus time data were analyzed simultaneously using population pharmacokinetic analysis with nonlinear mixed effects modeling. The parameters estimated were the apparent volume of distribution (V/F) and apparent oral clearance (CL/F). The rate constant of absorption (ka) was fixed to 23.7 day-1. The half-life of silver was calculated using half-life = ln(2)/k, where k = (CL/F)/(V/F).
次要结局
- Apparent Volume of Distribution of Silver (V/F)(Based on data collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application)
- Apparent Oral Clearance of Silver (CL/F)(Based on data collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application)
- Serum Silver Exposure (AUC)(Based on data collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application)