Study identifier:RDEA594-504
ClinicalTrials.gov identifier:NCT03272425
EudraCT identifier:N/A
CTIS identifier:N/A
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.
Gout
Phase 1
Yes
lesinurad/allopurinol 200/300 FDC tablets, lesinurad/allopurinol 200/300 FDC tablets, lesinurad/allopurinol 200/300 FDC tablets, lesinurad/allopurinol 200/300 FDC tablets, lesinurad 200 mg, lesinurad 200 mg, lesinurad 200 mg, lesinurad 200 mg, allopurinol 300 mg, allopurinol 300 mg, allopurinol 300 mg, allopurinol 300 mg
All
32
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Nov 2018 by Ardea Biosciences, Inc.
Ardea Biosciences, Inc.
-
No locations available
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 |