A randomized, open-label, single dose three period cross-over study to evaluate the bioequivalence of OXAYDO® (oxycodone) 15 mg compared to Roxicodone® (Oxycodone) 15 mg in healthy subjects

Trial Profile

A randomized, open-label, single dose three period cross-over study to evaluate the bioequivalence of OXAYDO® (oxycodone) 15 mg compared to Roxicodone® (Oxycodone) 15 mg in healthy subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 20 Jun 2017

At a glance

  • Drugs Oxycodone (Primary)
  • Indications Pain
  • Focus Pharmacokinetics
  • Most Recent Events

    • 20 Jun 2017 According to an Egalet Corporation media release, based on the data from this trial, company recieved complete response letter from the US FDA, requesting more information regarding the effect of food on oxycodone hydrochloride 15mg and the intranasal abuse-deterrent properties of oxycodone hydrochloride 10mg and 15mg.
    • 15 May 2017 According to an Egalet Corporation media release, results from this trial will be presented at the 36th Annual American Pain Society (APS) meeting.
    • 18 Apr 2017 According to an Egalet Corporation media release, based on the data from this trial a prior approval supplement (PAS) for OXAYDO tablets seeking approval of 10 mg and 15 mg dosage strengths, has been accepted for filing by the U.S. Food and Drug Administration (FDA). The FDA is anticipated to review the OXAYDO 10/15 mg PAS by the goal date of 17June 2017.
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