Study to Compare Bioavailability and Pharmacokinetics of a Novel Furosemide Regimen Administered … (NCT07269496) | Clinical Trial Compass
CompletedPhase 1
Study to Compare Bioavailability and Pharmacokinetics of a Novel Furosemide Regimen Administered Subcutaneously Versus the Same Dose (80 mg) Administered Intravenously in Healthy Volunteers
United Kingdom16 participantsStarted 2026-02-09
Plain-language summary
The trial is to compare the bioavailability of the original European Lasix (furosemide injection) administered in accordance with its prescribing information with the same dose of a novel furosemide formulation developed for this subcutaneous administration. The study will also investigate PK and PD of these regimens.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Written informed consent
* Male or female ≥18 years of age
* BMI between 18.5 and 32.0 kg/m2 (inclusive)
* Females will be non-pregnant and non-lactating
* Able to participate in the study in the opinion of the Investigator
* Has the ability to understand the requirements of the study and is willing to comply with all study procedures
Exclusion Criteria:
* Unable to consent to inclusion in study
* eGFR \< 60 mL/min/1.73 m2
* Use of diuretics
* Systolic blood pressure (SBP) \<90 mmHg
* Potassium \< 3.5 or \> 5.3 mmol/L
* Sodium \< 133 or \> 146 mmol/L
* Comorbidities or health issues which in the opinion of the investigator may interfere with study participation or study assessments.
* Major surgery within 30 days prior to Screening.
* Administration of an investigational drug or implantation of investigational device, or participation in another interventional trial, within 30 days prior to Screening, or 5 half-lives, whichever is longer.
* Pregnancy or breastfeeding
* Any contraindications for furosemide administration as per furosemide SmPC
* Any surgical or medical conditions, which in the opinion of the investigator may pose an undue risk to the participant, interfere with participation in the study or which may affect the integrity of the data
* Any clinically significant findings in Screening laboratory results which in the opinion of the investigator may pose an undue risk to the participant, interfere with participation in the study or which m…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Absolute bioavailability
Timeframe: From enrollment to end of treatment, 30 days