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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| female | Experimental | The healthy female volunteers receive furosemide and aminohippurate sodium "PAH" as single dose randomised on day 1 or day 2. |
|
| male | Experimental | The healthy male volunteers receive furosemide and aminohippurate sodium "PAH" as single dose randomised on day 1 or day 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide | Drug | Injection, 40 mg, single dose over 5 min |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| pharmacogenetic parameters | Influence of various genetic polymorphism (OAT1, OAT 4, OATP1B1, NKCC2, NCC, ENaC) on the variability of pharmacokinetic of furosemide | day 1 |
| pharmacokinetic of aminohippuric acid |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Eschenhagen, Prof.Dr.med. | Institut für Experimentelle und Klinische Pharmakologie und Toxikologie Universitätsklinikum Hamburg-Eppendorf Martinistr. 52 20246 Hamburg GERMANY | Study Director |
| Ulrike Werner, PD Dr. | Institut für Experimentelle und Klinische Pharmakologie und Toxikologie Universitätsklinikum Hamburg-Eppendorf Martinistr. 52 20246 Hamburg GERMANY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center North | Hamburg | 20246 | Germany |
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| ID | Term |
|---|---|
| D003075 | Coitus |
| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| D010130 | p-Aminohippuric Acid |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| aminohippurate sodium | Drug | Injection, 500 mg, single dose over 5 min |
|
|
gender-specific comparison of renal and systemic PAH clearance with the clearance of furosemide
| day 1 or day 2 |
| 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 |
| 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 |
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D000618 | Aminohippuric Acids |
| D006626 | Hippurates |
| D001549 | Benzamides |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D007651 | Keto Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |