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