MedTrace Logo

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

NCT04384653 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-09-20

No results posted yet for this study

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 30 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 primary objective of the study is to estimate the absolute bioavailability of furosemide administered by subcutaneous infusion compared with an equivalent dose of furosemide administered by IV bolus administration.

Conditions

Interventions

DRUG

Furosemide Injection Solution for subcutaneous administration (80 mg)

Furosemide Injection Solution for subcutaneous administration (80 mg)

DRUG

Furosemide Injection, USP

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

DEVICE

Medfusion 3500 (v6) precision infusion pump

Furosemide Injection Solution for subcutaneous administration (80 mg)

Sponsors & Collaborators

  • Accel Clinical Services

    collaborator INDUSTRY

  • SQ Innovation, Inc.

    lead INDUSTRY

Principal Investigators

  • Bruce G Rankin, DO, CPI, FACOFP · Accel Research Sites - DeLand Clinical Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-17
Primary Completion
2021-06-12
Completion
2021-06-12
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04384653 on ClinicalTrials.gov