Pharmacokinetics of Advantage Arrest in Healthy Children 13-Months to 13-Years of Age
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Fluoride Cmax
研究概览
简要总结
The purpose of this study is to further characterize basic pharmacokinetic (PK) parameters in healthy children to contribute to evidence for the safety of silver diamine fluoride (SDF; Advantage Arrest). Children with at least one active cavity will be treated and then have blood draws at random time points afterwards.
详细描述
The FDA requested additional data to evaluate the pharmacokinetics of silver diamine fluoride (SDF, Advantage Arrest) in children 13 months to 13 years old. The first request is for children under 36 months of age to be included in a study. The second request is for serum silver concentration be evaluated for a longer duration post-application to better estimate the half-life of silver and return of serum silver to baseline levels in children.
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
- 13 Months 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least one untreated caries lesion into the dentin
- •Live within 10 miles of study site
排除标准
- •oral mucositis
- •ulcerative oral lesions
- •hypersensitivity to silver or fluoride
- •history of treatment with silver diamine fluoride within 3 months
研究组 & 干预措施
Silver diamine fluoride
Silver diamine fluoride, 38%, topical, single application
干预措施: 38% silver diamine fluoride (Drug)
结局指标
主要结局
Fluoride Cmax
时间窗: 21 days
Maximum serum concentration of fluoride
Fluoride Tmax
时间窗: 21 days
Time to maximum serum concentration of fluoride
Area Under Curve, Fluoride
时间窗: 21 days
Area under the curve, fluoride
Area Under Curve, Silver
时间窗: 21 days
Area under the curve, silver
Silver Cmax
时间窗: 21 days
Maximum serum concentration of silver
Silver Tmax
时间窗: 21 days
Time to maximum serum concentration of silver
次要结局
未报告次要终点