Investigation of Gender Specificity of the Effects of Furosemide in Healthy Female and Male Volunteers
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- pharmacodynamic parameter of furosemide (Sodium excretion in the urine)
研究概览
简要总结
In this study the gender specificity of the effects of furosemide in female and male volunteers will be investigated. The main objective is gender-specific comparison of the pharmacokinetic parameters of furosemide in relation to the effect of furosemide (urinary excretion). Secondary objectives are the gender-specific comparison of renal and systemic PAH clearance with the clearance of furosemide and the influence of various genetic polymorphisms on the variability of furosemide pharmacokinetics.
详细描述
In this study the gender specificity of the effects of furosemide in female and male volunteers will be investigated. The healthy volunteers receive 1. furosemide and 2. aminohippurate sodium "PAH" as single dose. The main objective is gender-specific comparison of the pharmacokinetic parameters of furosemide in relation to the effect of furosemide (urinary excretion). Secondary objectives are the gender-specific comparison of renal and systemic PAH clearance with the clearance of furosemide and the influence of various genetic polymorphisms on the variability of furosemide pharmacokinetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer for medical history and physical examination findings
- •18 years, <40 years
- •Written informed consent is given
- •No clinically relevant changes in laboratory parameters
- •Inconspicuous current ECG
- •taking medication under a different drug trial within the last 30 days
排除标准
- •concomitant medication at study days or a week before
- •allergies or known hypersensitivity reactions to furosemide or aminohippurate sodium
- •decreased creatinine clearance by Cockcroft-Gault (<100 ml / min)
- •current drug abuses
- •opiate addiction within the last 10 years
- •smoking within the last year
- •pregnancy and 6 months postpartum, lactation
- •deprivation of legal capacity
- •Cooperation inability
研究组 & 干预措施
female
The healthy female volunteers receive furosemide and aminohippurate sodium "PAH" as single dose randomised on day 1 or day 2.
干预措施: Furosemide (Drug)
female
The healthy female volunteers receive furosemide and aminohippurate sodium "PAH" as single dose randomised on day 1 or day 2.
干预措施: aminohippurate sodium (Drug)
male
The healthy male volunteers receive furosemide and aminohippurate sodium "PAH" as single dose randomised on day 1 or day 2
干预措施: Furosemide (Drug)
male
The healthy male volunteers receive furosemide and aminohippurate sodium "PAH" as single dose randomised on day 1 or day 2
干预措施: aminohippurate sodium (Drug)
结局指标
主要结局
pharmacodynamic parameter of furosemide (Sodium excretion in the urine)
时间窗: day 1 or day 2
Gender-specific comparison of effect of furosemide on urinary excretion (sodium)
pharmacokinetic parameter of furosemide (AUC-24)
时间窗: day 1 or day 2
Gender-specific comparison of the pharmacokinetic parameters of furosemide (AUC-24). The sample size calculation for this study was conducted with respect to the expected gender difference in the AUC24 of furosemide.
次要结局
- other pharmacokinetic parameter of furosemide(day 1 or day 2)
- pharmacogenetic parameters(day 1)
- pharmacokinetic of aminohippuric acid(day 1 or day 2)
- other pharmacodynamic parameter of furosemide(day 1 or day 2)