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?

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.

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

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 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
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Back to top