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

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.

Study Overview

• Status: Withdrawn
• Conditions: Healthy Male and Female Volunteers
• Intervention / Treatment: Drug: Furosemide; Drug: aminohippurate sodium

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Clinical Trial Center North

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: female; The healthy female volunteers receive furosemide and aminohippurate sodium "PAH" as single dose randomised on day 1 or day 2.	Drug: Furosemide; Injection, 40 mg, single dose over 5 min; Other Names: ATC code: C03CA01; Product name: Lasix 40 mg Injektionslösung; Drug: aminohippurate sodium; Injection, 500 mg, single dose over 5 min; Other Names: ATC code: V04CH30,; Product name: Aminohipppurate Sodium "PAH"
Experimental: male; The healthy male volunteers receive furosemide and aminohippurate sodium "PAH" as single dose randomised on day 1 or day 2	Drug: Furosemide; Injection, 40 mg, single dose over 5 min; Other Names: ATC code: C03CA01; Product name: Lasix 40 mg Injektionslösung; Drug: aminohippurate sodium; Injection, 500 mg, single dose over 5 min; Other Names: ATC code: V04CH30,; Product name: Aminohipppurate Sodium "PAH"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	day 1 or day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pharmacogenetic parameters	Influence of various genetic polymorphism (OAT1, OAT 4, OATP1B1, NKCC2, NCC, ENaC) on the variability of pharmacokinetic of furosemide	day 1
pharmacokinetic of aminohippuric acid	gender-specific comparison of renal and systemic PAH clearance with the clearance of furosemide	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)	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)	day 1 or day 2

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Study Director: Thomas Eschenhagen, Prof.Dr.med., Institut für Experimentelle und Klinische Pharmakologie und Toxikologie Universitätsklinikum Hamburg-Eppendorf Martinistr. 52 20246 Hamburg GERMANY; Principal Investigator: Ulrike Werner, PD Dr., Institut für Experimentelle und Klinische Pharmakologie und Toxikologie Universitätsklinikum Hamburg-Eppendorf Martinistr. 52 20246 Hamburg GERMANY

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2012
• Primary Completion (Anticipated): June 1, 2012
• Study Completion (Anticipated): June 1, 2012

Study Registration Dates

• First Submitted: July 1, 2010
• First Submitted That Met QC Criteria: July 1, 2010
• First Posted (Estimate): July 2, 2010

Study Record Updates

• Last Update Posted (Actual): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: gender, diuretics, furosemide, aminohippuric acid
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Potassium Chloride Symporter Inhibitors; Furosemide
• Other Study ID Numbers: IPT0901