Pharmacokinetics and Bioavailability Comparison of Novel Furosemide Regimen in Chronic Heart Failure Patients
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.
Furosemide Injection Solution for subcutaneous administration (80 mg)
+ Furosemide Injection, USP
+ Medfusion 3500 (v6) precision infusion pump
Cardiovascular Diseases
+ Heart Diseases
+ Heart Failure
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy 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
Accel Research Sites - DeLand Clinical Research Unit
DeLand, United StatesOpen Accel Research Sites - DeLand Clinical Research Unit in Google Maps