This study will assess the relative bioavailability of lesinurad tablets, manufactured at two different sites.
A change in manufacturing site of lesinurad tablets has been implemented. This study is intended to evaluate the clinical comparability of lesinurad tablets manufactured at the two different sites by assessing relevant clinical Pharmacokinetics (PK) parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
36
Unnamed facility
Glendale, California, United States
PK profile of lesinurad from plasma
PK endpoints in terms of maximum observed concentration (Cmax); time of occurrence of maximum observed concentration (Tmax); area under the plasma concentration time curve (AUC); and apparent terminal half-life (t1/2).
Time frame: Day 1 and Day 5
Incidence of Adverse Events
Changes in Laboratory, Electrocardiogram and Vital Signs Parameters
Time frame: 5 weeks
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