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.

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.

Recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2017

At a glance

  • Drugs Sodium oxybate (Primary) ; Sodium oxybate
  • Indications Narcolepsy
  • Focus Pharmacokinetics; Registrational
  • Sponsors Avadel Pharmaceuticals
  • Most Recent Events

    • 06 Nov 2017 New trial record
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top