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A phase I bioavailability study of granisetron [APF 530] in healthy volunteers.

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Trial Profile

A phase I bioavailability study of granisetron [APF 530] in healthy volunteers.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 02 May 2016

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At a glance

  • Drugs Granisetron (Primary) ; Granisetron (Primary)
  • Indications Chemotherapy-induced nausea and vomiting
  • Focus Pharmacokinetics; Registrational
  • Sponsors A.P. Pharma

    • Most Recent Events

    • 18 Apr 2016 According to a Heron Therapeutics media release, the US FDA has indicated that there are no substantive deficiencies in the NDA and has begun labeling discussions with the Company.
    • 04 Jun 2013 Results presented at the 49th Annual Meeting of the American Society of Clinical Oncology.
    • 26 Oct 2012 The US FDA accepted a New Drug Application for granisetron, according to an A.P. Pharma media release.

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