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

Study identifier:RDEA594-504

ClinicalTrials.gov identifier:NCT03272425

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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.

Medical condition

Gout

Phase

Phase 1

Healthy volunteers

Yes

Study drug

lesinurad/allopurinol 200/300 FDC tablets, lesinurad/allopurinol 200/300 FDC tablets, lesinurad/allopurinol 200/300 FDC tablets, lesinurad/allopurinol 200/300 FDC tablets, lesinurad 200 mg, lesinurad 200 mg, lesinurad 200 mg, lesinurad 200 mg, allopurinol 300 mg, allopurinol 300 mg, allopurinol 300 mg, allopurinol 300 mg

Sex

All

Actual enrollment

32

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 14 Aug 2017
Primary Completion Date: 04 Oct 2017
Study Completion Date: 04 Oct 2017

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2018 by Ardea Biosciences, Inc.

Sponsors

Ardea Biosciences, Inc.

Collaborators

-

Inclusion and exclusion criteria