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

Universitätsklinikum Hamburg-Eppendorf

Status and phase: Withdrawn; Phase 4

Conditions: Healthy Male and Female Volunteers

Treatments: Drug: aminohippurate sodium; Drug: Furosemide

Study type: Interventional

Funder types: Other

Identifiers

NCT01156220

IPT0901

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

female

Experimental group

Description:

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

Treatment:

Drug: Furosemide

Drug: aminohippurate sodium

male

Experimental group

Description:

The healthy male volunteers receive furosemide and aminohippurate sodium "PAH" as single dose randomised on day 1 or day 2

Treatment:

Drug: Furosemide

Drug: aminohippurate sodium