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 200 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.
