A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Assess the Abuse Potential of the Hydrocodone Bitartrate Extended-Release Tablet in Healthy, Nondependent, Recreational Opioid Users

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Assess the Abuse Potential of the Hydrocodone Bitartrate Extended-Release Tablet in Healthy, Nondependent, Recreational Opioid Users

Completed
Phase of Trial: Phase I

Latest Information Update: 01 Jan 2017

At a glance

  • Drugs Hydrocodone (Primary)
  • Indications Pain
  • Focus Adverse reactions
  • Sponsors Cephalon
  • Most Recent Events

    • 25 Feb 2015 According to a Teva Pharmaceutical Industries media release, the US FDA has accepted for review an NDA supported in part by results of this study and another study investigating the abuse potential of CEP 33237.
    • 08 Oct 2014 Data from this study will support the NDA submission to the US FDA which is expected to be completed by the end of 2014, according to a Teva Pharmaceutical Industries media release.
    • 11 May 2013 Results presented at the 32nd Annual Scientific Meeting of the American Pain Society.
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