A bioequivalence study of RedHill BioPharma's controlled-release ondansetron for the prevention of cancer-related nausea and vomiting.

Trial Profile

A bioequivalence study of RedHill BioPharma's controlled-release ondansetron for the prevention of cancer-related nausea and vomiting.

Completed
Phase of Trial: Phase III

Latest Information Update: 02 May 2013

At a glance

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

    • 02 May 2013 NDA filing, based on the results of this trial, is expected during the first or second quarter of 2014, according to a RedHIll media release.
    • 25 Feb 2013 Following this trial, RedHill Biopharma met with the US FDA to discuss the filing of an NDA for RHB 102, according to a company media release.
    • 18 Apr 2012 Status changed from active, no longer recruiting to completed, according to a RedHill Biopharma media release.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top