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 comparative, open label, randomized, 2 periods, 2 sequence crossover study to assess the relative bioavailability of sodium oxybate for extended release oral suspension (FT218) formulation (single dose administered at the dose of 6g) versus the marketed reference Xyrem (at the dose of 2 x 3g ) in healthy volunteers

Next Previous
Trial Profile

A comparative, open label, randomized, 2 periods, 2 sequence crossover study to assess the relative bioavailability of sodium oxybate for extended release oral suspension (FT218) formulation (single dose administered at the dose of 6g) versus the marketed reference Xyrem (at the dose of 2 x 3g ) in healthy volunteers

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Mar 2021

Price :
$35 *
Note:
  • 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 Sodium oxybate (Primary)
  • Indications Narcolepsy
  • Focus Pharmacokinetics; Registrational
  • Sponsors Avadel Pharmaceuticals

Most Recent Events

  • 22 Feb 2021 Results from Four crossover, single-dose studies published in the Clinical Therapeutics
  • 01 May 2020 Results assessing relative bioavailability of investigational once-nightly sodium oxybate, FT218, 6 g, compared to commercially available twice-nightly sodium oxybate and the food effect of FT218, presented at the 72nd Annual Meeting of the American Academy of Neurology.
  • 16 May 2019 Status changed from recruiting to completed.

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

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: 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