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

Completed
Phase of Trial: Phase II/III

Latest Information Update: 02 Nov 2017

At a glance

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

    • 02 Nov 2017 According to a scPharmaceuticals media release, the 505(b)(2) New Drug Application (NDA) for Furoscix has been accepted for filing by the U.S. Food and Drug Administration (FDA). Under the Prescription Drug User Fee Act (PDUFA), the FDA has set an action date of June 23, 2018.
    • 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.
    • 20 Sep 2016 Results published in a scPharmaceuticals media release.
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