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An Open Label, Single Dose, Randomised, Parallel Group Pharmacokinetic Study to Evaluate a Combination Product Containing Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects Administered at Three Doses.

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Trial Profile

An Open Label, Single Dose, Randomised, Parallel Group Pharmacokinetic Study to Evaluate a Combination Product Containing Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects Administered at Three Doses.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 20 Sep 2023

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At a glance

  • Drugs Naproxen sodium/sumatriptan (Primary)
  • Indications Migraine; Migraine with aura; Migraine without aura
  • Focus Pharmacokinetics; Registrational
  • Sponsors GlaxoSmithKline; GSK

    • Most Recent Events

    • 20 Apr 2015 In November 2014, Pernix submitted a sNDA seeking approval for Treximet for use in adolescent patients with acute treatment of migraine. Included in the filing were safety and efficacy data sets from this trial and two others conducted to evaluate the pharmacokinetic, efficacy, and long-term safety of Treximet for the acute treatment of adolescent migraine; the company expects approval for Treximet in adolescent patients in the second quarter of 2015, according to a Pernix media release.
    • 27 Jun 2010 Results were reported at the 52nd Annual Scientific Meeting of the American Headache Society.
    • 12 Oct 2009 New trial record

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