A Phase 1, Randomized, Open-Label, Replicate, Crossover Study to Assess the Bioequivalence of Lesinurad/Allopurinol Fixed-Dose Combination Tablets and Coadministered Lesinurad and Allopurinol Tablets in Fed Healthy Adult Subjects

Trial Profile

A Phase 1, Randomized, Open-Label, Replicate, Crossover Study to Assess the Bioequivalence of Lesinurad/Allopurinol Fixed-Dose Combination Tablets and Coadministered Lesinurad and Allopurinol Tablets in Fed Healthy Adult Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 21 Jun 2017

At a glance

  • Drugs Allopurinol/lesinurad (Primary) ; Allopurinol; Lesinurad
  • Indications Gout
  • Focus Pharmacokinetics
  • Sponsors Ardea Biosciences
  • Most Recent Events

    • 15 Jun 2017 Status changed from active, no longer recruiting to completed.
    • 04 Jan 2017 According to an Ironwood Pharmaceuticals media release,the US FDA accepted for review a NDA for DUZALLO (fixed-dose combination of lesinurad and allopurinol). The FDA Prescription Drug User Fee Act (PDUFA) target action date is expected to occur in the second half of 2017.
    • 21 Sep 2016 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