NCT02581553

Lesinurad/Allopurinol 200/300 FDC Tablets Bioavailability

A Phase 1, Randomized, Open-Label, Crossover Study to Assess the Relative Bioavailability of Lesinurad/Allopurinol Fixed Dose Combination Tablets and Coadministered Lesinurad and Allopurinol Tablets and the Effect of Food on the Pharmacokinetics of Lesinurad/Allopurinol Fixed Dose Combination Tablets in Healthy Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Ardea Biosciences, Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will assess relative bioavailability of lesinurad/allopurinol fixed dose combination (FDC), its individual components and the effect of food.

Detailed description

The study comprises 2 parts. Part 1 will assess the relative BA of lesinurad/allopurinol FDC and monocomponents in fasted subjects. Part 2 will assess the effect of food on the PK of FDC tablets.

Conditions

• Healthy

Interventions

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

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-07-01
• Completion: 2016-08-01
• First posted: 2015-10-21
• Last updated: 2016-12-19

Locations

1 site across 1 country: United States