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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Male and Female Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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female

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

Group Type EXPERIMENTAL

Furosemide

Intervention Type DRUG

Injection, 40 mg, single dose over 5 min

aminohippurate sodium

Intervention Type DRUG

Injection, 500 mg, single dose over 5 min

male

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

Group Type EXPERIMENTAL

Furosemide

Intervention Type DRUG

Injection, 40 mg, single dose over 5 min

aminohippurate sodium

Intervention Type DRUG

Injection, 500 mg, single dose over 5 min

Interventions

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Furosemide

Injection, 40 mg, single dose over 5 min

Intervention Type DRUG

aminohippurate sodium

Injection, 500 mg, single dose over 5 min

Intervention Type DRUG

Other Intervention Names

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ATC code: C03CA01 Product name: Lasix 40 mg Injektionslösung ATC code: V04CH30, Product name: Aminohipppurate Sodium "PAH"

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes