Pivotal single-dose bioavailability trial of chlorphenamine/codeine (CCP 01).
Phase of Trial: Phase I
Latest Information Update: 01 May 2015
At a glance
- Drugs Chlorphenamine/codeine (Primary)
- Indications Common cold; Cough
- Focus Pharmacokinetics
- Sponsors Vernalis
- 01 May 2015 Vernalis and Tris Pharma received FDA approval of the NDA for Tuzistra XR (chlorpheniramine/codeine), according to a media release; the approval was based on data from this single-dose trial and the pivotal multi-dose trial.
- 01 Jul 2014 An NDA was submitted to the US FDA based on results from this trial.
- 28 Nov 2013 New trial record