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NCT02329834 · ClinicalTrials.gov registry record · Phase 2
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 2 study, sponsored by scPharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT02329834: Completed Phase 2 study, sponsored by scPharmaceuticals.
NCT02329834 is a Phase 2 study that has completed, run by scPharmaceuticals. The registered enrollment target is 23 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02329834, a Phase 2 study, has completed, sponsored by scPharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 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 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.
Interventions
- DRUG Fursemide Injection Solution for subcutaneous administration (80 mg)
- DRUG Furosemide Injection, USP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2015-04 |
| Est. Completion | 2015-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02329834
The ClinicalTrials.gov registry entry for NCT02329834 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is scPharmaceuticals, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Fursemide Injection Solution for subcutaneous administration (80 mg) is the first listed.
NCT02329834 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02329834 about?
NCT02329834 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 NCT02329834?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2015-04. Estimated completion is 2015-10.
What interventions are being tested in trial NCT02329834?
The interventions under investigation include: Fursemide Injection Solution for subcutaneous administration (80 mg) (DRUG), Furosemide Injection, USP (DRUG).
Who is sponsoring clinical trial NCT02329834?
This trial is sponsored by scPharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
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