Open label single dose two way two period crossover study in 15 healthy volunteers
Research type
Research Study
Full title
An Open-label, Single-dose, Randomized, Two-way, Two-period Crossover Study to Compare Bioavailability and Pharmacokinetics of a Novel Furosemide Regimen Administered Subcutaneously Versus the Same Dose (80 mg) Administered Intravenously in Healthy Volunteers
IRAS ID
1013098
Contact name
Pieter Muntendam
Contact email
Sponsor organisation
SQ Innovation Inc.
Research summary
SQ Innovation are developing a new formulation of furosemide, SQIN-Furosemide. Furosemide is one of a group of medicines called diuretics, which are used to help patients lose extra water in their body very quickly, through their urine. SQIN-Furosemide has been developed to be administered subcutaneously (under the skin), using an infusion pump, over a period of 5 hours.
This study is being conducted to investigate whether the amount of furosemide delivered to the body using SQIN-Furosemide (test product) is the same as the amount delivered using an approved formulation of furosemide (comparator product) administered in two 10-minute intravenous injections, 2 hours apart.
The study will be conducted in 15 healthy adult participants at a single research clinic. Each participant will receive a single dose of the test product and the comparator product across two dosing occasions, at least 7 days apart. Approximately half of the participants will receive the test product on the first dosing occasion, followed by the comparator on the second dosing occasion, and the remaining participants will receive the treatment in the opposite order. The order of treatments will be decided at random.
Participants will be admitted to the clinic on the day of dosing. They will have regular blood tests and will need to collect their urine for up to 24 hours, so that the levels of furosemide and its diuretic effect can be measured. Participants will continue to stay in the clinic for 24 hours following dosing. During this time they will also be monitored for safety, which will include measurement of vital signs (heart rate, breathing rate, body temperature and blood pressure), blood and urine tests.
REC name
London - Riverside Research Ethics Committee
REC reference
25/LO/0876
Date of REC Opinion
14 Jan 2026
REC opinion
Further Information Favourable Opinion