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Crossover Study to Compare the Pharmacokinetics and Bioavailability of a Novel Furosemide Regimen Administered Subcutaneously vs. the Same Dose Administered Intravenously in Subjects With Chronic Heart Failure

NCT02329834 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2022-12-02

Study results available
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Summary

The proposed study aims to compare the pharmacokinetics and bioavailability of intravenous and subcutaneous Furosemide. Although these regimens are not intended to be bioequivalent, they are both expected to achieve therapeutic plasma levels and induce effective diuresis.

The test formulation in this study is a buffered solution, Furosemide Injection Solution at 8 mg/mL at pH 7.4 (range 7.0 to 7.8) and is intended for SC injection according to the instructions in the protocol. A commercial formulation of Furosemide Injection, USP will serve as the reference drug in this study, which will be administered by IV bolus. It contains furosemide 10 mg/mL in solution at alkaline pH of 8.0 to 9.3 and is marketed for IV and IM injection.

The objectives of this study are:

* To characterize the pharmacokinetics of furosemide administered by continuous subcutaneous infusion using a biphasic delivery profile.
* To estimate the absolute bioavailability of furosemide administered by continuous subcutaneous infusion compared with an equivalent dose of furosemide administered by intravenous bolus administration.

Conditions

Interventions

DRUG

Fursemide Injection Solution for subcutaneous administration (80 mg)

Furosemide Injection Solution, 10mL of undiluted buffered furosemide solution (8mg/mL)

DRUG

Furosemide Injection, USP

Furosemide Injection, USP (10mg/mL), 80 mg by intravenous administration.

Sponsors & Collaborators

  • scPharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Bruce G. Rankin, DO, CPI, MRO, FACOFP · Avail Clnical Research, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-10-31
Completion
2015-10-31

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 NCT02329834 on ClinicalTrials.gov