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临床试验/NCT00572884
NCT00572884已完成不适用

CCRC:Identification and Development of Biological Markers of Human Exposure to the Insecticide Permethrin

University of California, Davis2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2006年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6
试验地点
2
主要终点
Concentration of individual metabolites in urine

研究概览

简要总结

Military personnel are exposed to the insecticide permethrin when using the DOD Insect Repellent System. A urinary metabolite of permethrin that is in high abundance and is relatively stable may be an ideal biomarker of exposure to this pesticide. Monitoring such a biomarker can prevent over-exposure. The objectives are to identify the most abundant human urinary metabolite following dermal exposure; to utilize this information to develop rapid laboratory-based and field portable methods to monitor the degree of an individual's exposure to permethrin.

详细描述

Permethrin is applied to the forearm of the subject and remains for 8 hours. The exposed area is then washed with soap and water several times. 24 hour urine samples are collected at daily intervals for 192 hours. Blood and saliva samples are taken at pre-dose, 1, 3, 6, 9 12, 24, 48, 72, 96, 120, 144, 168 and 192 hours. Subjects must return to the clinic daily to drop off urine collections and have blood and saliva samples taken.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • self-report healthy adult men and premenopausal women

排除标准

  • unusual alcohol, drug, cigarette use for last 3 years
  • unusual exercise program for last 3 years
  • under the care of a physician for a disease
  • participated in any radioactive drug study
  • lactating
  • people who rely more on their arm due to illness or injury
  • people with neurological or musculoskeletal diseases
  • use of permethrin in the last 6 months
  • people who apply pesticides as their primary occupation

结局指标

主要结局

Concentration of individual metabolites in urine

时间窗: 192 hours

次要结局

  • total carbon-14 in serum(192 hours)
  • Total carbon-14 in saliva(192 hours)
  • Total carbon-14 in urine samples(192 hours)

研究者

申办方类型
Other

研究点 (2)

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