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 200 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