Lesinurad/Allopurinol 200/300 FDC Tablets Bioequivalence

Study identifier:RDEA594-503

ClinicalTrials.gov identifier:NCT02888054

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1, Randomized, Open-Label, Replicate, Crossover Study to Assess the Bioequivalence of Lesinurad/Allopurinol Fixed-Dose Combination Tablets and Coadministered Lesinurad and Allopurinol Tablets in Fed Healthy Adult Subjects

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

lesinurad/allopurinol 200/300 FDC tablet, lesinurad/allopurinol 200/300 FDC tablet, lesinurad/allopurinol 200/300 FDC tablet, lesinurad/allopurinol 200/300 FDC tablet, 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

28

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 30 Aug 2016
Primary Completion Date: 18 Oct 2016
Study Completion Date: 01 Feb 2017

Study design

Allocation: Randomized
Endpoint Classification: Bio-equivalence
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2017 by Ardea Biosciences, Inc.

Sponsors

Ardea Biosciences, Inc.

Collaborators

-

Inclusion and exclusion criteria