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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Universitätsklinikum Hamburg-Eppendorf.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01156220
First received: July 1, 2010
Last updated: April 11, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy Male and Female Volunteers
 Drug: Furosemide
Drug: aminohippurate sodium
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigation of Gender Specificity of the Effects of Furosemide in Healthy Female and Male Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • pharmacokinetic parameter of furosemide (AUC-24) [ Time Frame: day 1 or day 2 ] [ Designated as safety issue: No ]
    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.

  • pharmacodynamic parameter of furosemide (Sodium excretion in the urine) [ Time Frame: day 1 or day 2 ] [ Designated as safety issue: No ]
    Gender-specific comparison of effect of furosemide on urinary excretion (sodium)


Secondary Outcome Measures:
  • pharmacogenetic parameters [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    Influence of various genetic polymorphism (OAT1, OAT 4, OATP1B1, NKCC2, NCC, ENaC) on the variability of pharmacokinetic of furosemide

  • pharmacokinetic of aminohippuric acid [ Time Frame: day 1 or day 2 ] [ Designated as safety issue: No ]
    gender-specific comparison of renal and systemic PAH clearance with the clearance of furosemide

  • other pharmacokinetic parameter of furosemide [ Time Frame: day 1 or day 2 ] [ Designated as safety issue: No ]
    Gender-specific comparison of the other pharmacokinetic parameters of furosemide (Cmax, tmax, t½, CLoral, CLren)

  • other pharmacodynamic parameter of furosemide [ Time Frame: day 1 or day 2 ] [ Designated as safety issue: No ]
    Gender-specific comparison of effect of furosemide on urinary excretion (chloride, potassium, uric acid, calcium, magnesium, creatinine)


Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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"

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01156220

Contacts
Contact: Ulrike Werner, PD Dr. 040-741055058 uwerner@uke.de

Locations
Germany
Clinical Trial Center North Not yet recruiting
Hamburg, Germany, 20246
Contact: Alen Jambrecina, Dr. med.     +49 40 7410 51603     a.jambrecina@uke.de    
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Prof. Dr. med. Thomas Eschenhagen, Institut für Pharmakologie und Toxikologie
ClinicalTrials.gov Identifier: NCT01156220     History of Changes
Other Study ID Numbers: IPT0901
Study First Received: July 1, 2010
Last Updated: April 11, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
gender, diuretics, furosemide, aminohippuric acid

Additional relevant MeSH terms:
Furosemide
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013