Lesinurad Tablet Bioequivalence
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/5/2014 |
| Start Date: | April 2014 |
| End Date: | July 2014 |
| Contact: | C. Winnett |
| Phone: | 858.652.6649 |
A Phase 1, Randomized, Open-Label, Crossover Study to Assess the Bioequivalence of Lesinurad Tablets From Two Manufacturing Sites in Healthy Adult Male Subjects
This study will assess the bioequivalence of lesinurad tablets manufactured at two different
sites.
sites.
This study is intended to evaluate the clinical comparability of lesinurad tablets
manufactured at the 2 different sites by assessing relevant clinical Pharmacokinetics (PK)
parameters.
manufactured at the 2 different sites by assessing relevant clinical Pharmacokinetics (PK)
parameters.
Inclusion Criteria:
- Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40
kg/m2.
- Subject has a Screening serum urate level ≤ 7 mg/dL. ˗ Subject is free of any
clinically significant disease or medical condition, per the Investigator's judgment.
Exclusion Criteria:
- Subject has any gastrointestinal disorder that affects motility and/or absorption.
- Subject has a history or suspicion of kidney stones.
- Subject has undergone major surgery within 3 months prior to Screening.
- Subject has donated blood or experienced significant blood loss (> 450 mL) within 12
weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to the Screening
visit.
- Subject has inadequate venous access or unsuitable veins for repeated venipuncture.
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