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

Trial Profile

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

Completed
Phase of Trial: Phase I

Latest Information Update: 18 Apr 2016

At a glance

  • Drugs Granisetron (Primary)
  • Indications Chemotherapy-induced nausea and vomiting
  • Focus Pharmacodynamics; 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.
    • 16 Oct 2012 The US FDA accepted a New Drug Application for granisetron, according to an A.P. Pharma media release.
    • 09 Aug 2011 Planned initiation date changed to 1 Dec 2011.
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