Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT04384653
PHASE1/PHASE2

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

Sponsor: SQ Innovation, Inc.

View on ClinicalTrials.gov

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.

Official title: An Open-label, Single-dose, Randomized, Two-way, Two-period Crossover Study to Compare the Pharmacokinetics and Bioavailability of a Novel Furosemide Regimen Administered Subcutaneously Versus the Same Dose (80 mg) Administered Intravenously in Subjects With Chronic Heart Failure

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2020-10-17

Completion Date

2021-06-12

Last Updated

2026-06-15

Healthy Volunteers

No

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)

Locations (1)

Accel Research Sites - DeLand Clinical Research Unit

DeLand, Florida, United States