Healthy Male and Female VolunteersPhase 4NCT01156220
Investigation of Gender Specificity of the Effects of Furosemide in Healthy Female and Male Volunteers
A Phase 4 study testing Furosemide and aminohippurate sodium in people with Healthy Male and Female Volunteers, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Male and Female Volunteers
- What is being tested?
- Furosemide and aminohippurate sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Jun 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- pregnancy and 6 months postpartum, lactation
- deprivation of legal capacity
- Cooperation inability
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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
- Healthy Male and Female Volunteers
- Being tested
- Furosemide, aminohippurate sodium
- Keywords
- gender, diuretics, furosemide, aminohippuric acid
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideDrug
Also called ATC code: C03CA01, Product name: Lasix 40 mg Injektionslösung
Injection, 40 mg, single dose over 5 min
aminohippurate sodiumDrug
Also called ATC code: V04CH30,, Product name: Aminohipppurate Sodium "PAH"
Injection, 500 mg, single dose over 5 min
| Study group | Role | What they receive |
|---|---|---|
| female | Experimental | The healthy female volunteers receive furosemide and aminohippurate sodium "PAH" as single dose randomised on day 1 or day 2. Receives: Drug: Furosemide; Drug: aminohippurate sodium |
| male | Experimental | The healthy male volunteers receive furosemide and aminohippurate sodium "PAH" as single dose randomised on day 1 or day 2 Receives: Drug: Furosemide; Drug: aminohippurate sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: day 1 or day 2
Secondary outcomes (4)
pharmacogenetic parameters
Influence of various genetic polymorphism (OAT1, OAT 4, OATP1B1, NKCC2, NCC, ENaC) on the variability of pharmacokinetic of furosemide
Measured: day 1
pharmacokinetic of aminohippuric acid
gender-specific comparison of renal and systemic PAH clearance with the clearance of furosemide
Measured: 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)
Measured: 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)
Measured: day 1 or day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startJan 2012 (estimated)
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Why it stopped: Study was never implemented.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male and Female VolunteersStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Eschenhagen, Prof.Dr.med., Study director, Institut für Experimentelle und Klinische Pharmakologie und Toxikologie Universitätsklinikum Hamburg-Eppendorf Martinistr. 52 20246 Hamburg GERMANYUlrike Werner, PD Dr., Principal investigator, Institut für Experimentelle und Klinische Pharmakologie und Toxikologie Universitätsklinikum Hamburg-Eppendorf Martinistr. 52 20246 Hamburg GERMANY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156220
- Sponsor's protocol ID
- IPT0901
- Status last verified
- Jun 2022
- First submitted
- 1 Jul 2010
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Gender Specificity of the Effects of Furosemide in Healthy Female and Male Volunteers
- ClinicalTrials.gov ID
- NCT01156220
- Acronym / sponsor ID
- IPT0901
- Conditions
- Healthy Male and Female Volunteers
- Keywords
- gender, diuretics, furosemide, aminohippuric acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never implemented.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Jan 2012 (estimated)
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 2 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| female | Experimental | Drug: Furosemide, Drug: aminohippurate sodiumThe healthy female volunteers receive furosemide and aminohippurate sodium "PAH" as single dose randomised on day 1 or day 2. |
| male | Experimental | Drug: Furosemide, Drug: aminohippurate sodiumThe healthy male volunteers receive furosemide and aminohippurate sodium "PAH" as single dose randomised on day 1 or day 2 |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FurosemideAlso: ATC code: C03CA01, Product name: Lasix 40 mg InjektionslösungInjection, 40 mg, single dose over 5 min | Drug | female, male |
| aminohippurate sodiumAlso: ATC code: V04CH30,, Product name: Aminohipppurate Sodium "PAH"Injection, 500 mg, single dose over 5 min | Drug | female, male |
Primary outcome
pharmacokinetic parameter of furosemide (AUC-24)
Time frame: day 1 or day 2
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
Gender-specific comparison of effect of furosemide on urinary excretion (sodium)
4 secondary outcomes
pharmacogenetic parameters
Time frame: day 1
pharmacokinetic of aminohippuric acid
Time frame: day 1 or day 2
other pharmacokinetic parameter of furosemide
Time frame: day 1 or day 2
other pharmacodynamic parameter of furosemide
Time frame: day 1 or day 2
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Eschenhagen, Prof.Dr.med. study director
Institut für Experimentelle und Klinische Pharmakologie und Toxikologie Universitätsklinikum Hamburg-Eppendorf Martinistr. 52 20246 Hamburg GERMANY
Ulrike Werner, PD Dr. principal investigator
Institut für Experimentelle und Klinische Pharmakologie und Toxikologie Universitätsklinikum Hamburg-Eppendorf Martinistr. 52 20246 Hamburg GERMANY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Furosemide and aminohippurate sodium in people with Healthy Male and Female Volunteers, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pharmacokinetic parameter of furosemide (AUC-24) (time frame: day 1 or day 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.