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

Phase 4

Withdrawn

• Conditions: Healthy Male and Female Volunteers
• Interventions: Drug: Furosemide; Drug: aminohippurate sodium

• Registration Number: NCT01156220
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Study Timeline

• Study First Submitted: 2010-07-01
• Study First Submitted QC: 2010-07-01
• Study First Posted: 2010-07-02
• Study Start: 2012-01
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-29
• Last Update Posted: 2022-07-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
male	aminohippurate sodium	The healthy male volunteers receive furosemide and aminohippurate sodium "PAH" as single dose randomised on day 1 or day 2
female	Furosemide	The healthy female volunteers receive furosemide and aminohippurate sodium "PAH" as single dose randomised on day 1 or day 2.
female	aminohippurate sodium	The healthy female volunteers receive furosemide and aminohippurate sodium "PAH" as single dose randomised on day 1 or day 2.
male	Furosemide	The healthy male volunteers receive furosemide and aminohippurate sodium "PAH" as single dose randomised on day 1 or day 2

Primary Outcome Measures

Name	Time	Method
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)
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.

Secondary Outcome Measures

Name	Time	Method
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)
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 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)

Trial Locations

Locations (1)

Clinical Trial Center North; 🇩🇪 Hamburg, Germany