Lesinurad Tablet Bioequivalence
Study identifier:RDEA594-132
ClinicalTrials.gov identifier:NCT02127775
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 1, Randomized, Open-Label, Crossover Study to Assess the Bioequivalence of Lesinurad Tablets from Two Manufacturing Sites in Healthy Adult Male Subjects
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Lesinurad 400 mg (manufactured at Site 1), Lesinurad 400 mg (manufactured at Site 2)
Sex
Male
Actual Enrollment
54
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 01 Apr 2014
Primary Completion Date: 01 Jun 2014
Study Completion Date: 01 Jul 2014
Study design
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Sept 2014 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 B Day 1: Lesinurad 400 mg (manufactured at Site 2); Day 5: Lesinurad 400 mg (manufactured at Site 1) | - |
| Experimental: Sequence A Day 1: Lesinurad 400 mg (manufactured at Site 1); Day 5: Lesinurad 400 mg (manufactured at Site 2) | - |
Contacts
Investigators
Principal Investigator
J. Hall
Ardea Biosciences, Inc.
