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
Phase of Trial: Phase I
Latest Information Update: 21 Aug 2017
At a glance
- Drugs Allopurinol/lesinurad (Primary) ; Allopurinol; Lesinurad
- Indications Gout
- Focus Pharmacokinetics
- Sponsors Ardea Biosciences
- 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.