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

• Status: Withdrawn
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Treatments: Furosemide

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