A pilot trial will assess the bioequivalence of ondansetron administered as a orally dissolving thin film strip [Zuplenz; MonoSol Rx, Strativa Pharmaceuticals] and as an orally dissolving tablet [Zofran; GlaxoSmithKline] for the prevention of nausea and vomiting induced by moderate or highly emetogenic chemotherapy or radiotherapy.

Trial Profile

A pilot trial will assess the bioequivalence of ondansetron administered as a orally dissolving thin film strip [Zuplenz; MonoSol Rx, Strativa Pharmaceuticals] and as an orally dissolving tablet [Zofran; GlaxoSmithKline] for the prevention of nausea and vomiting induced by moderate or highly emetogenic chemotherapy or radiotherapy.

Completed
Phase of Trial: Phase II

Latest Information Update: 30 Nov 2017

At a glance

  • Drugs Ondansetron (Primary)
  • Indications Chemotherapy-induced nausea and vomiting; Nausea and vomiting; Radiotherapy-induced nausea and vomiting
  • Focus Pharmacokinetics
  • Sponsors MonoSol Rx; Par Specialty Pharmaceuticals
  • Most Recent Events

    • 30 Nov 2017 According to a Aquestive Therapeutics media release, MonoSol Rx changed its name to Aquestive Therapeutics
    • 02 Dec 2008 New source identified and integrated (media release from Strativa)
    • 25 Feb 2008 New trial record.
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