Investigation of Gender Specificity of the Effects of Furosemide in Healthy Female and Male Volunteers
Overview
- Phase
- Phase 4
- Intervention
- Furosemide
- Conditions
- Healthy Male and Female Volunteers
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Locations
- 1
- Primary Endpoint
- pharmacodynamic parameter of furosemide (Sodium excretion in the urine)
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
female
The healthy female volunteers receive furosemide and aminohippurate sodium "PAH" as single dose randomised on day 1 or day 2.
Intervention: Furosemide
female
The healthy female volunteers receive furosemide and aminohippurate sodium "PAH" as single dose randomised on day 1 or day 2.
Intervention: aminohippurate sodium
male
The healthy male volunteers receive furosemide and aminohippurate sodium "PAH" as single dose randomised on day 1 or day 2
Intervention: Furosemide
male
The healthy male volunteers receive furosemide and aminohippurate sodium "PAH" as single dose randomised on day 1 or day 2
Intervention: aminohippurate sodium
Outcomes
Primary Outcomes
pharmacodynamic parameter of furosemide (Sodium excretion in the urine)
Time Frame: day 1 or day 2
Gender-specific comparison of effect of furosemide on urinary excretion (sodium)
pharmacokinetic parameter of furosemide (AUC-24)
Time Frame: 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.
Secondary Outcomes
- 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)