NCT02127775

Lesinurad Tablet Bioequivalence

A Phase 1, Randomized, Open-Label, Crossover Study to Assess the Bioequivalence of Lesinurad Tablets From Two Manufacturing Sites in Healthy Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Ardea Biosciences, Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will assess the bioequivalence of lesinurad tablets manufactured at two different sites.

Detailed description

This study is intended to evaluate the clinical comparability of lesinurad tablets manufactured at the 2 different sites by assessing relevant clinical Pharmacokinetics (PK) parameters.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Lesinurad 400 mg (manufactured at Site 1)
DRUG	Lesinurad 400 mg (manufactured at Site 2)

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-06-01
• Completion: 2014-07-01
• First posted: 2014-05-01
• Last updated: 2014-09-22

Locations

1 site across 1 country: United States