Lesinurad Tablet Bioequivalence

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ardea Biosciences, Inc.
• Treatments: Lesinurad

Criteria

Inclusion Criteria:

• Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2.

• Subject has a Screening serum urate level ≤ 7 mg/dL. ˗ Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.

Exclusion Criteria:

• Subject has any gastrointestinal disorder that affects motility and/or absorption.

• Subject has a history or suspicion of kidney stones.

• Subject has undergone major surgery within 3 months prior to Screening.

• Subject has donated blood or experienced significant blood loss (> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to the Screening visit.

• Subject has inadequate venous access or unsuitable veins for repeated venipuncture.