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

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.

Collaborators

Inclusion and exclusion criteria

Location

CAEP - Centro Avançado de Estudos e Pesquisas Ltda.

Campinas, Sao Paulo, Brazil

Arms	Assigned Interventions
Experimental: Sequence ABBA Treatment A: Lesinurad/Allopurinol FDC Tablets – 200/300 mg (test product); Treatment B: lesinurad, tablets, 200 mg + Zyloric®, allopurinol, tablet, 300 mg (comparator 1 + comparator 2).	Drug: lesinurad/allopurinol 200/300 FDC tablets Test Drug Drug: lesinurad 200 mg Comparator 1 Drug: allopurinol 300 mg Comparator 2
Experimental: Sequence BABA Treatment A: Lesinurad/Allopurinol FDC Tablets – 200/300 mg (test product); Treatment B: lesinurad, tablets, 200 mg + Zyloric®, allopurinol, tablet, 300 mg (comparator 1 + comparator 2).	Drug: lesinurad/allopurinol 200/300 FDC tablets Test Drug Drug: lesinurad 200 mg Comparator 1 Drug: allopurinol 300 mg Comparator 2
Experimental: Sequence ABAB Treatment A: Lesinurad/Allopurinol FDC Tablets – 200/300 mg (test product); Treatment B: lesinurad, tablets, 200 mg + Zyloric®, allopurinol, tablet, 300 mg (comparator 1 + comparator 2).	Drug: lesinurad/allopurinol 200/300 FDC tablets Test Drug Drug: lesinurad 200 mg Comparator 1 Drug: allopurinol 300 mg Comparator 2
Experimental: Sequence BAAB Treatment A: Lesinurad/Allopurinol FDC Tablets – 200/300 mg (test product); Treatment B: lesinurad, tablets, 200 mg + Zyloric®, allopurinol, tablet, 300 mg (comparator 1 + comparator 2).	Drug: lesinurad/allopurinol 200/300 FDC tablets Test Drug Drug: lesinurad 200 mg Comparator 1 Drug: allopurinol 300 mg Comparator 2

"There is no result for the study"

Documents available

Trial Results Summaries
Available here

Contacts

Contact

C. Winnett

(858) 652-6649

cwinnett@ardeabio.com

Investigators

Principal Investigator

N. Bhakta

Ardea Biosciences, Inc.