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 200 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