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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Mar 2021

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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.
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