Lesinurad/Allopurinol 200/300 FDC Tablets Bioavailability

Study identifier:RDEA594-501

ClinicalTrials.gov identifier:NCT02581553

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1, Randomized, Open-Label, Crossover Study to Assess the Relative Bioavailability of Lesinurad/Allopurinol Fixed Dose Combination Tablets and Coadministered Lesinurad and Allopurinol Tablets and the Effect of Food on the Pharmacokinetics of Lesinurad/Allopurinol Fixed Dose Combination Tablets in Healthy Adult Male Subjects

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

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

Sex

Male

Actual Enrollment

116

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Oct 2015
Primary Completion Date: 01 Jul 2016
Study Completion Date: 01 Aug 2016

Study design

Allocation: Randomized
Endpoint Classification: Bio-availability
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