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/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
Sex
All
Actual enrollment
32
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.
Sponsors
Ardea Biosciences, Inc.
Collaborators
-
Inclusion and exclusion criteria
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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 |
Contacts
Investigators
Principal Investigator
N. Bhakta
Ardea Biosciences, Inc.
