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

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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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