Healthy Male and Female Volunteers Clinical Trial
Official title:
Investigation of Gender Specificity of the Effects of Furosemide in Healthy Female and Male Volunteers
| NCT number | NCT01156220 |
| Other study ID # | IPT0901 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | January 2012 |
| Est. completion date | June 2012 |
| Verified date | June 2022 |
| Source | Universitätsklinikum Hamburg-Eppendorf |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | June 2012 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 39 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Clinical Trial Center North | Hamburg |
| Lead Sponsor | Collaborator |
|---|---|
| Universitätsklinikum Hamburg-Eppendorf |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | pharmacokinetic parameter of furosemide (AUC-24) | 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. | day 1 or day 2 | |
| Primary | pharmacodynamic parameter of furosemide (Sodium excretion in the urine) | Gender-specific comparison of effect of furosemide on urinary excretion (sodium) | day 1 or day 2 | |
| Secondary | pharmacogenetic parameters | Influence of various genetic polymorphism (OAT1, OAT 4, OATP1B1, NKCC2, NCC, ENaC) on the variability of pharmacokinetic of furosemide | day 1 | |
| Secondary | pharmacokinetic of aminohippuric acid | gender-specific comparison of renal and systemic PAH clearance with the clearance of furosemide | day 1 or day 2 | |
| Secondary | other pharmacokinetic parameter of furosemide | Gender-specific comparison of the other pharmacokinetic parameters of furosemide (Cmax, tmax, t½, CLoral, CLren) | day 1 or day 2 | |
| Secondary | other pharmacodynamic parameter of furosemide | Gender-specific comparison of effect of furosemide on urinary excretion (chloride, potassium, uric acid, calcium, magnesium, creatinine) | day 1 or day 2 |