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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: Completed Phase 1 study, sponsored by SQ Innovation.
NCT04384653 is a Phase 1 study that has completed, run by SQ Innovation. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Relative absolute bioavailability of furosemide based on AUC last
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 |
What the finished NCT04384653 record still lists
NCT04384653 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 3 interventions - of which Furosemide Injection, USP is the first listed.
NCT04384653 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04384653's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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