Toxicokinetic Study of Dichlorobisphenol A After an Oral or Dermal Single Dose in Healthy Volunteer.
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
The objective of this study is to determine toxicokinetic parameters of deuterated d12-Cl2BPA after the administration of a single low dose (50 µg/kg) to healthy volunteers via oral or dermal routes.
详细描述
Dichlorobisphenol A (Cl2BPA)is formed by the reaction of chlorine with bisphenol A present in water during water disinfection process. As a consequence, Cl2BPA is present in various aqueous media including tap water. Cl2BPA has also been found in human, in blood, urine, breast milk and adipose tissue suggesting chronic exposure to this compound. Cl2BPA is an endocrine disruptor that binds to estrogenic and PPAR-γ receptors. Epidemiological studies have shown that exposure to DCBPA has been related to the occurrence of diabetes, obesity and myocardial infarction.
Currently, no toxicokinetic data are available to estimate the disposition (ADME) of Cl2BPA after oral and dermal exposure in human while these data are needed for proper risk assessment of this compound.
The objective of this study is to determine toxicokinetic parameters of deuterated d12-Cl2BPA after the administration of a single low dose (50 µg/kg) to healthy volunteers via oral or dermal routes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 51 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-51 year old
- •No current disease
- •BMI range: 18.5-24.9 kg/m²,
- •Non smoker
- •Normal renal function
- •Normal hepatic function
- •Normal gastrointestinal function
- •Affiliated to national health insurance
- •Having signed an informed consent
排除标准
- •Renal function ≤ 90 ml/min/1.73 m² (CKD-EPI)
- •Altered hepatic function ASAT > 50 UI/L and/or ALAT > 50 UI/L,
- •Current disease,
- •Heavy alcohol consumption
- •No treatment susceptible to alter Cl2BPA toxicokinetics (drugs that interact with metabolic enzymes or transporter proteins,, anti-acids, etc)
- •Pregnant women, lactating mothers and women of childbearing potential with no reliable medical contraception
研究组 & 干预措施
Oral route
Volunteers receiving d12-Cl2BPA via oral route
干预措施: Administration of d12-Cl2BPA (Other)
Dermal route
Volunteers receiving d12-Cl2BPA via oral route
干预措施: Administration of d12-Cl2BPA (Other)
结局指标
主要结局
Cmax
时间窗: Hour 0-Hour 24
Non-compartmental and compartmental toxicokinetic analysis
Total clearance
时间窗: Hour 0 - Hour 24
Non-compartmental and compartmental toxicokinetic analysis
Volume of distribution
时间窗: Hour 0 - Hour 24
Non-compartmental and compartmental toxicokinetic analysis
Area under the plasma concentration versus time curve (AUC)
时间窗: Hour 0-Hour 24
Non-compartmental and compartmental toxicokinetic analysis
次要结局
- Secondary toxicokinetic parameters(Hour 0 - Hour 24)