Clinical trial NCT01156220: Investigation of Gender Specificity of the Effects of Furosemide in Healthy Female and Male Volunteers
Official title: Investigation of Gender Specificity of the Effects of Furosemide in Healthy Female and Male Volunteers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Healthy Male and Female Volunteers
Keywords: gender, diuretics, furosemide, aminohippuric acid
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2010-07-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: pharmacokinetic parameter of furosemide (AUC-24)
timeFrame: day 1 or day 2
measure: pharmacodynamic parameter of furosemide (Sodium excretion in the urine)
timeFrame: day 1 or day 2
Secondary outcomes:
measure: pharmacogenetic parameters
timeFrame: day 1
measure: pharmacokinetic of aminohippuric acid
timeFrame: day 1 or day 2
measure: other pharmacokinetic parameter of furosemide
timeFrame: day 1 or day 2
measure: other pharmacodynamic parameter of furosemide
timeFrame: day 1 or day 2
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Clinical Trial Center North
Study officials:
affiliation: Institut für Experimentelle und Klinische Pharmakologie und Toxikologie Universitätsklinikum Hamburg-Eppendorf Martinistr. 52 20246 Hamburg GERMANY
name: Thomas Eschenhagen, Prof.Dr.med.
role: STUDY_DIRECTOR
affiliation: Institut für Experimentelle und Klinische Pharmakologie und Toxikologie Universitätsklinikum Hamburg-Eppendorf Martinistr. 52 20246 Hamburg GERMANY
name: Ulrike Werner, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: