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Trial Profile

A Pivotal Multiple-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 multiple-dose trial and the pivotal single-dose trial.
01 Jul 2014 An NDA was submitted to the US FDA based on results from this trial.
24 Feb 2014 Status changed from not yet recruiting to completed, as reported by a media release.

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