Pivotal multiple-dose bioavailability trial of chlorphenamine/codeine (CCP 01).

Trial Profile

Pivotal multiple-dose bioavailability trial of chlorphenamine/codeine (CCP 01).

Completed
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
  • 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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