Phase I study of benzhydrocodone [KemPharm] in volunteers

Trial Profile

Phase I study of benzhydrocodone [KemPharm] in volunteers

Phase of Trial: Phase I

Latest Information Update: 19 Nov 2012

At a glance

  • Drugs Benzhydrocodone (Primary) ; Hydrocodone/paracetamol
  • Indications Acute pain
  • Focus Pharmacokinetics; Registrational
  • Most Recent Events

    • 19 Nov 2012 Based on results of this trial, KemPharm receives positive feedback from the US FDA on further clinical studies required for the approval of KP 201 under the 505(b)(2) regulatory pathway, according to a company media release.
    • 22 May 2012 Status changed from recruiting to completed, according to a KemPharm media release.
    • 24 May 2011 Topline pharmacokinetics data reported in a KemPharm media release.
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