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NCT04384653 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by SQ Innovation.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT04384653 is a Phase 1 study that has completed, run by SQ Innovation. The registered enrollment target is 20 participants.
The verdict
NCT04384653, a Phase 1 study, has completed, sponsored by SQ Innovation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
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.
Interventions
- DRUG Furosemide Injection, USP
- DRUG Furosemide Injection Solution for subcutaneous administration (80 mg)
- DEVICE Medfusion 3500 (v6) precision infusion pump
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-10-17 |
| Est. Completion | 2021-06-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04384653
The ClinicalTrials.gov registry entry for NCT04384653 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SQ Innovation, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Furosemide Injection, USP is the first listed.
NCT04384653 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04384653 about?
NCT04384653 is a clinical study titled "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". 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 th...
What is the current status of trial NCT04384653?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2020-10-17. Estimated completion is 2021-06-12.
What interventions are being tested in trial NCT04384653?
The interventions under investigation include: Furosemide Injection, USP (DRUG), Furosemide Injection Solution for subcutaneous administration (80 mg) (DRUG), Medfusion 3500 (v6) precision infusion pump (DEVICE).
Who is sponsoring clinical trial NCT04384653?
This trial is sponsored by SQ Innovation, which has 2 total clinical trials registered on ClinicalTrials.gov.
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