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COMPLETED
NCT07269496
PHASE1

Study to Compare Bioavailability and Pharmacokinetics of a Novel Furosemide Regimen Administered Subcutaneously Versus the Same Dose (80 mg) Administered Intravenously in Healthy Volunteers

Sponsor: SQ Innovation, Inc.

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2026-02-09

Completion Date

2026-03-09

Last Updated

2026-04-22

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

SQIN-Furosemide

SQIN-Furosemide is a novel formulation of furosemide at 30mg/mL at pH 7.5 (range 7.1 to 7.8) intended for subcutaneous use.

DRUG

Lasix ® Infusion

Sanofi Aventis 20mg/2mL Lasix infusion. 80mg IV bolus administered over 2 doses of 40mg each for 10 mins, 2 hours apart (4mg/min).

Locations (1)

BDD Pharma

Glasgow, Scotland, United Kingdom