Completed

Pharmacokinetics and Bioavailability Comparison of Novel Furosemide Regimen in Chronic Heart Failure Patients

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Study Aim

This study aims to compare the bioavailability and pharmacokinetics of a novel furosemide regimen in patients with chronic heart failure, specifically focusing on the relative absolute bioavailability following a 5-hour subcutaneous infusion.

What is being tested

Furosemide Injection Solution for subcutaneous administration (80 mg)

+ Furosemide Injection, USP

+ Medfusion 3500 (v6) precision infusion pump

DrugDevice
Who is being recruted

Cardiovascular Diseases

+ Heart Diseases

+ Heart Failure

From 18 to 80 Years
+33 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: October 2020
See protocol details

Summary

Principal SponsorSQ Innovation, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 17, 2020

Actual date on which the first participant was enrolled.

This study focuses on comparing the effectiveness of a new way to administer furosemide, a common heart failure medication, in adults with mild to moderate heart failure. Currently, furosemide is often given orally or through an IV. The study aims to test a novel method of delivering the drug subcutaneously, or under the skin, and compare it to the traditional IV method. The goal is to see if this new method can provide the same benefits as the IV method, potentially making treatment more convenient and comfortable for patients. This research is important as it could lead to improved care and quality of life for individuals with heart failure. During the study, participants will be randomly assigned to receive furosemide either subcutaneously or intravenously, and then will switch to the other method after a short break. This is known as a 'crossover' study design. Participants will need to stay in a clinical research unit for each treatment period and will be asked to limit their sodium intake before each visit. The study will measure how well the body absorbs and uses the drug under each delivery method. This is done by comparing the 'area under the curve' (AUC) of furosemide in the bloodstream after subcutaneous and IV administration. The AUC is a standard way to measure how much of a drug is in the body over a certain period of time.

Official TitleAn Open-label, Single-dose, Randomized, Two-way, Two-period Crossover Study to Compare the Pharmacokinetics and Bioavailability of a Novel Furosemide Regimen Administered Subcutaneously Versus the Same Dose (80 mg) Administered Intravenously in Subjects With Chronic Heart Failure
NCT04384653
Principal SponsorSQ Innovation, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesHeart Failure

Criteria

8 inclusion criteria required to participate
An Institutional Review Board (IRB)-approved informed consent is signed and dated prior to any study-related activities.

Male and female subjects ≥18 and ≤ 80 years of age, with body weight <130 kg and body mass index (BMI) <38 kg/m2.

Females will be non-pregnant, non-lactating, or post-menopausal, or surgically sterile (e.g., tubal ligation, hysterectomy),

Females of childbearing potential will use TWO of the following forms of contraception: intrauterine device (IUD), IUD with spermicide, female condom with spermicide, contraceptive sponge with spermicide, an intravaginal system, diaphragm with spermicide, cervical cap with spermicide, a male sexual partner who agrees to use a male condom with spermicide, a sterile sexual partner.

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25 exclusion criteria prevent from participating
Acute Decompensated Heart Failure (ADHF) or recent history of hospitalization for heart failure in the last 4 weeks.

Worsening of signs or symptoms of heart failure in the two weeks prior to the Screening, or those expected to require IV loop diuretics or inpatient treatment for heart failure during the study.

Systolic blood pressure (SBP) <90 mmHg.

Temperature ≥38°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Furosemide Injection Solution for subcutaneous administration (80 mg) over 5 hours for Treatment Period 1 and IV Furosemide Injection, USP (80 mg) by IV bolus for Treatment Period 2

Group II

Experimental
IV Furosemide Injection, USP (80 mg) by IV bolus for Treatment Period 1 and Furosemide Injection Solution for subcutaneous administration (80 mg) over 5 hours for Treatment Period 2

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Accel Research Sites - DeLand Clinical Research Unit

DeLand, United StatesOpen Accel Research Sites - DeLand Clinical Research Unit in Google Maps
CompletedOne Study Center
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