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 range18 Years
SexALL
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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 ā„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 mā¦
What they're measuring
1
Absolute bioavailability
Timeframe: From enrollment to end of treatment, 30 days