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

NCT07269496 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-04-22

No results posted yet for this study

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.

Conditions

  • Healthy

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).

Sponsors & Collaborators

  • BDD Pharma Ltd

    collaborator INDUSTRY

  • SQ Innovation, Inc.

    lead INDUSTRY

Principal Investigators

  • Lyn Cory, MD · BDD Pharma Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-09
Primary Completion
2026-03-09
Completion
2026-03-09
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07269496 on ClinicalTrials.gov