Healthy Male and Female Volunteers
Conditions
Keywords
gender, diuretics, furosemide, aminohippuric acid
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.
Interventions
DRUGFurosemide
Injection, 40 mg, single dose over 5 min
DRUGaminohippurate sodium
Injection, 500 mg, single dose over 5 min
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pharmacokinetic parameter of furosemide (AUC-24) | 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. |
| pharmacodynamic parameter of furosemide (Sodium excretion in the urine) | day 1 or day 2 | Gender-specific comparison of effect of furosemide on urinary excretion (sodium) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pharmacogenetic parameters | day 1 | Influence of various genetic polymorphism (OAT1, OAT 4, OATP1B1, NKCC2, NCC, ENaC) on the variability of pharmacokinetic of furosemide |
| pharmacokinetic of aminohippuric acid | day 1 or day 2 | gender-specific comparison of renal and systemic PAH clearance with the clearance of furosemide |
| other pharmacokinetic parameter of furosemide | day 1 or day 2 | Gender-specific comparison of the other pharmacokinetic parameters of furosemide (Cmax, tmax, t½, CLoral, CLren) |
| other pharmacodynamic parameter of furosemide | day 1 or day 2 | Gender-specific comparison of effect of furosemide on urinary excretion (chloride, potassium, uric acid, calcium, magnesium, creatinine) |
Countries
Germany
Outcome results
None listed