NCT03272425

Lesinurad/Allopurinol 200/300 Fixed-Dose Combination (FDC) Tablets Bioequivalence.

A Randomized, Open-label, Replicate, Crossover, 4-period Study to Assess the Bioequivalence of Lesinurad/Allopurinol Fixed-dose Combination 200/300 mg Tablets From Ardea Biosciences, Inc. (Test Drug) Versus Lesinurad, 200 mg Tablet From AstraZeneca (Comparator 1) Coadministered With Zyloric®, Allopurinol 300 mg Tablet From Aspen Pharma Industria Farmaceutica Ltda. (Comparator 2) in Healthy Female and Male Adult Subjects, Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Ardea Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To assess the bioequivalence between lesinurad/allopurinol 200/300 FDC tablets and coadministered lesinurad and allopurinol tablets in the fasted state based on the pharmacokinetic (PK) evaluation of lesinurad and allopurinol in healthy adult subjects.

Conditions

• Gout

Interventions

Type	Name	Description
DRUG	lesinurad/allopurinol 200/300 FDC tablets	Test Drug
DRUG	lesinurad 200 mg	Comparator 1
DRUG	allopurinol 300 mg	Comparator 2

Timeline

• Start date: 2017-08-14
• Primary completion: 2017-10-04
• Completion: 2017-10-04
• First posted: 2017-09-05
• Last updated: 2018-11-07

Locations

1 site across 1 country: Brazil