Study identifier:RDEA594-503
ClinicalTrials.gov identifier:NCT02888054
EudraCT identifier:N/A
CTIS identifier:N/A
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
Healthy
Phase 1
Yes
lesinurad/allopurinol 200/300 FDC tablet, lesinurad/allopurinol 200/300 FDC tablet, lesinurad/allopurinol 200/300 FDC tablet, lesinurad/allopurinol 200/300 FDC tablet, 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
28
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Bio-equivalence
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Jun 2017 by Ardea Biosciences, Inc.
Ardea Biosciences, Inc.
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Sequence ABBA Day 1: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) Day 8: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) Day 15: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) Day 22: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) | - |
Experimental: Sequence BABA Day 1: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) Day 8: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) Day 15: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) Day 22: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) | - |
Experimental: Sequence ABAB Day 1: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) Day 8: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) Day 15: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) Day 22: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) | - |
Experimental: Sequence BAAB Day 1: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) Day 8: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) Day 15: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) Day 22: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) | - |