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?

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

Next Previous
X
Search
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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 17 Sep 2021

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

    • Most Recent Events

    • 21 Aug 2017 According to an Ironwood Pharmaceuticals media release, DUZALLO (fixed-dose combination of lesinurad and allopurinol) has been approved by the US FDA as a once-daily oral treatment for hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with a medically appropriate daily dose of allopurinol alone. The FDA approval of DUZALLO was based on the clinical program supporting the ZURAMPIC (lesinurad) NDA and this trial.
    • 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.

You need to be a logged in or subscribed to view this content Request demo

If your organization or you do not have a subscription, try one of the following:
  • Contacting your organization’s admin about adding this content to your AdisInsight subscription
  • Buying a PDF version of any individual profile
  • Request a free trial
If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top