A Randomized, Placebo-Controlled, Four-Period Crossover Definitive QT Study Of The Effects of APF530 Exposure, High-Dose IV Granisetron and Moxifloxacin on QTc Prolongation
Phase of Trial: Phase I
Latest Information Update: 18 Apr 2016
At a glance
- Drugs Granisetron (Primary) ; Granisetron (Primary) ; Moxifloxacin
- Indications Chemotherapy-induced nausea and vomiting
- Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics; Registrational
- Sponsors Heron Therapeutics
- 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.
- 26 Mar 2012 Status changed from active, no longer recruiting to completed, according to an A.P. Pharma media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History