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A Phase I, Bioequivalence Study to Evaluate Two Formulations of Bendamustine (BDM) Hydrochloride (HCl) Administered to Cancer Patients

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Trial Profile

A Phase I, Bioequivalence Study to Evaluate Two Formulations of Bendamustine (BDM) Hydrochloride (HCl) Administered to Cancer Patients

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 09 Jun 2021

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At a glance

  • Drugs Bendamustine (Primary)
  • Indications Cancer; Haematological malignancies; Solid tumours
  • Focus Pharmacokinetics
  • Sponsors Eagle Pharmaceuticals

    • Most Recent Events

    • 10 May 2021 According to a Eagle Pharmaceuticals media release, the company has filed TREAKISYM RI (50ml) liquid formulation with the Pharmaceuticals and Medical Devices Agency ("PMDA") in Japan, based on data from this study.
    • 31 May 2017 Results published in the Journal of Clinical Pharmacology
    • 29 Sep 2015 According to an Eagle Pharmaceuticals media release, the Prescription Drug User Fee Act (PDUFA) goal date for a decision on the NDA by the FDA is December 2015.

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