Trial Profile

A Pivotal Single-Dose Bioavailability Trial of Chlorphenamine/Codeine (CCP 01)

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 05 May 2015

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At a glance

Drugs Chlorphenamine/codeine (Primary)
Indications Common cold; Cough
Focus Pharmacokinetics
Sponsors Vernalis

Most Recent Events

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

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