Trial Profile

A phase I metabolism study of granisetron [APF 530] in healthy volunteers.

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 02 May 2016

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At a glance

Drugs Granisetron (Primary)
Indications Chemotherapy-induced nausea and vomiting
Focus Pharmacodynamics; Registrational
Sponsors A.P. Pharma

Most Recent Events

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.

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