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A Phase 1, Randomized, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Fulvestrant (Test vs. Reference) Following Intramuscular Administration to the Gluteal Muscle in Healthy Female Subjects

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Trial Profile

A Phase 1, Randomized, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Fulvestrant (Test vs. Reference) Following Intramuscular Administration to the Gluteal Muscle in Healthy Female Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 30 Aug 2023

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At a glance

  • Drugs Fulvestrant (Primary)
  • Indications Breast cancer
  • Focus Pharmacokinetics
  • Sponsors Eagle Pharmaceuticals

    • Most Recent Events

    • 29 Aug 2023 According to an Eagle Pharmaceuticals media release, the company plans to file a new drug application (NDA) for EA-114 in 2024
    • 29 Aug 2023 According to an Eagle Pharmaceuticals media release, the company announced a positive Type C meeting with the U.S. Food and Drug Administration. Eagle and the FDA agreed on a path forward to advance the clinical development of EA-114 in the treatment of breast cancer in post-menopausal women.
    • 02 Jun 2021 Status changed from active, no longer recruiting to completed.

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