A phase I metabolism study of granisetron [APF 530] in healthy volunteers.
Phase of Trial: Phase I
Latest Information Update: 18 Apr 2016
At a glance
- Drugs Granisetron (Primary)
- Indications Chemotherapy-induced nausea and vomiting
- Focus Pharmacodynamics; Registrational
- Sponsors A.P. Pharma
- 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.
- 09 Aug 2011 Planned initiation date changed to 1 Dec 2011.