Investigation of Gender Specificity of the Effects of Furosemide in Healthy Female and Male Volunteers

Universitätsklinikum Hamburg-Eppendorf

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Healthy Male and Female Volunteers

Interventions

FurosemideDRUG

Injection, 40 mg, single dose over 5 min

aminohippurate sodiumDRUG

Injection, 500 mg, single dose over 5 min

Eligibility

Sex: ALLMin age: 18 YearsMax age: 39 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Clinical Trial Center North

Hamburg, Germany

Outcomes

Primary Outcomes

pharmacokinetic parameter of furosemide (AUC-24)

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.

Time frame: day 1 or day 2

pharmacodynamic parameter of furosemide (Sodium excretion in the urine)

Gender-specific comparison of effect of furosemide on urinary excretion (sodium)

Time frame: day 1 or day 2

Secondary Outcomes

pharmacogenetic parameters

Influence of various genetic polymorphism (OAT1, OAT 4, OATP1B1, NKCC2, NCC, ENaC) on the variability of pharmacokinetic of furosemide

Time frame: day 1

pharmacokinetic of aminohippuric acid

gender-specific comparison of renal and systemic PAH clearance with the clearance of furosemide

Time frame: day 1 or day 2

other pharmacokinetic parameter of furosemide

Gender-specific comparison of the other pharmacokinetic parameters of furosemide (Cmax, tmax, t½, CLoral, CLren)

Time frame: day 1 or day 2

other pharmacodynamic parameter of furosemide

Gender-specific comparison of effect of furosemide on urinary excretion (chloride, potassium, uric acid, calcium, magnesium, creatinine)

Time frame: day 1 or day 2

Data from ClinicalTrials.gov

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