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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 (80mg) Administered Intravenously in Subjects With Chronic Heart Failure

Trial Profile

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 (80mg) Administered Intravenously in Subjects With Chronic Heart Failure

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 21 Sep 2023

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At a glance

  • Drugs Furosemide (Primary) ; Furosemide (Primary)
  • Indications Chronic heart failure
  • Focus Pharmacokinetics; Registrational
  • Sponsors scPharmaceuticals
  • Most Recent Events

    • 19 Sep 2023 According to a scPharmaceuticals media release, company plans to report data from a pivotal pharmacokinetic (PK) study in first half of 2024, and submitting a Supplemental New Drug Application (sNDA) to the FDA by the end of 2024.
    • 10 Oct 2022 According to a scPharmaceuticals media release, USFDA has approved FUROSCIX (furosemide injection) delivered via an On-Body Infusor for the treatment of congestion due to fluid overload in adults with New York Heart Association Class II/III chronic heart failure, based on the IV equivalence established in this study.
    • 20 Sep 2016 According to a scPharmaceuticals media release, data from this study were presented at the 20th Annual Heart Failure Society of America (HFSA) Scientific Meeting 2016.
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