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Pharmacokinetics and Pharmacodynamics of Subcutaneous vs Intravenous Furosemide in Healthy Volunteers

NCT06167707 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-03-30

Study results available
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Summary

This study aims to compare the pharmacokinetics and pharmacodynamics of subcutaneous (SC) and intravenous (IV) furosemide. The test formulation in this study is furosemide injection, 80 mg/1 mL, buffered to a neutral pH for SC administration via an autoinjector. A commercial formulation of furosemide injection, USP, solution 10 mg/mL administered as a 40 mg IV injection over 2 minutes followed by a second dose of 40 mg, 2 hours later, will serve as the reference drug.

The objectives of this study are:

* To estimate the bioavailability and describe the pharmacokinetics and pharmacodynamics of furosemide administered as SC injection via autoinjector compared with equivalent dose of furosemide administered as two 40 mg IV injections, two hours apart.
* To describe the safety and tolerability of furosemide administered as SC injection via an autoinjector.

Conditions

Interventions

DRUG

SCP-111

Furosemide injection 80 mg/mL, 80 mg SC via autoinjector x 1 dose

DRUG

Furosemide USP

Furosemide injection, USP 10 mg/mL, 40 mg IV over 2 minutes followed by 40 mg 2 hours later

Sponsors & Collaborators

  • scPharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-19
Primary Completion
2024-06-14
Completion
2024-06-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT06167707 on ClinicalTrials.gov