Pharmacokinetics of Advantage Anti-Caries Varnish
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Observed Fluoride AUC
研究概览
简要总结
The study aim is to characterize the kinetics of iodine and fluoride following topical application of a combined PVP-I and NaF anti-dental caries varnish in healthy adults.
详细描述
The study was to characterize serum iodine and fluoride levels over 24 hours after application of a topical dental varnish in healthy adults 23 to 57 years old.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults 18 y and older, at least 20 teeth, not taking prescription or OTC medications.
排除标准
- •Pregnant, weighed less than 110 pounds, had oral mucositis, ulcerative lesions, sensitivity to shellfish or iodine or fluoride varnish, or had known hypothyroidism, hyperthyroidism, dermatitis herpetiformis, hypocomplementemic vasculitis, nodular thread with heart disease, multi nodular goiter, Graves disease, or autoimmune thyroiditis
研究组 & 干预措施
Anti-caries varnish
topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application
干预措施: Anti-caries varnish (Drug)
结局指标
主要结局
Observed Fluoride AUC
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Area under the Curve for observed fluoride in ng\*h/mL
Observed Fluoride Baseline-Corrected AUC
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Area under the Curve for observed fluoride in ng\*h/mL
Fluoride t1/2
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Terminal elimination half-life in hours for fluoride
Observed Fluoride Total Urinary Recovery
时间窗: baseline to 24 hours
Total urinary recovery in milligrams observed
Observed Iodine Tmax
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Time to maximum serum concentration of iodine in hours
Observed Iodine Cmax
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Maximum serum concentration of iodine in ng/mL
Observed Iodine Baseline-Corrected Cmax
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Maximum serum concentration of iodine in ng/mL
Observed Iodine Baseline-Corrected AUC
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Area under the Curve for observed iodine in ng\*h/mL
Observed Iodine Total Urinary Recovery
时间窗: baseline to 24 hours
Total urinary recovery in milligrams observed
Iodine t1/2
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Terminal elimination half-life of iodine in hours
Observed Fluoride Tmax
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Time to maximum serum concentration in hours
Observed Fluoride Cmax
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Maximum serum concentration of fluoride in ng/mL
Observed Fluoride Baseline-Corrected Cmax
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Maximum serum concentration of iodine in ng/mL
次要结局
未报告次要终点