NCT02888054

Lesinurad/Allopurinol 200/300 FDC Tablets Bioequivalence

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: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Ardea Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will assess the bioequivalence (BE) of Lesinurad/Allopurinol Fixed-Dose Combination (FDC) Tablets and Coadministered Lesinurad and Allopurinol Tablets in Fed Healthy Adult Subjects

Detailed description

The study will assess the BE between lesinurad/allopurinol 200/300 FDC tablets and coadministered lesinurad and allopurinol tablets in the fed state.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	lesinurad/allopurinol 200/300 FDC tablet
DRUG	lesinurad 200 mg
DRUG	allopurinol 300 mg

Timeline

• Start date: 2016-08-30
• Primary completion: 2016-10-18
• Completion: 2017-02-01
• First posted: 2016-09-02
• Last updated: 2017-06-16

Locations

1 site across 1 country: United States