Bioequivalence trial of extended-release ondansetron (RHB 102) vs Zofran

Trial Profile

Bioequivalence trial of extended-release ondansetron (RHB 102) vs Zofran

Phase of Trial: Phase I

Latest Information Update: 07 Mar 2015

At a glance

  • Drugs Ondansetron (Primary)
  • Indications Chemotherapy-induced nausea and vomiting; Radiotherapy-induced nausea and vomiting
  • Focus Pharmacokinetics; Registrational
  • Sponsors RedHill Biopharma
  • Most Recent Events

    • 30 Apr 2014 RedHill Biopharma plans to submit a European marketing application for RHB-102 for the prevention of chemotherapy and radiotherapy-induced nausea and vomiting in cancer patients in Q3 of 2014 based on the positive results from this study.
    • 07 Apr 2014 RedHill Biopharma expects to report results in July 2014.
    • 07 Apr 2014 Status changed from planning to recruiting, as reported in a RedHill Biopharma media release.
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