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A Randomized, Placebo-Controlled, Four-Period Crossover Definitive QT Study Of The Effects of APF530 Exposure, High-Dose IV Granisetron and Moxifloxacin on QTc Prolongation

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Trial Profile

A Randomized, Placebo-Controlled, Four-Period Crossover Definitive QT Study Of The Effects of APF530 Exposure, High-Dose IV Granisetron and Moxifloxacin on QTc Prolongation

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) ; Moxifloxacin
  • Indications Chemotherapy-induced nausea and vomiting
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics; Registrational
  • Sponsors Heron Therapeutics

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.
  • 26 Mar 2012 Status changed from active, no longer recruiting to completed, according to an A.P. Pharma media release.

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