Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

X
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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 11 Jul 2019

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

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.

You need to be a logged in or subscribed to view this content Request demo

If your organization or you do not have a subscription, try one of the following:
  • Contacting your organization’s admin about adding this content to your AdisInsight subscription
  • Buying a PDF version of any individual profile
  • Request a free trial
If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top