A Phase 1, Randomized, Open-Label, Crossover Study to Assess the Bioequivalence of Lesinurad Tablets From Two Manufacturing Sites in Healthy Adult Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- PK profile of lesinurad from plasma
研究概览
简要总结
This study will assess the bioequivalence of lesinurad tablets manufactured at two different sites.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m
- •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.
排除标准
- •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.
研究组 & 干预措施
Sequence B
Day 1: Lesinurad 400 mg (manufactured at Site 2); Day 5: Lesinurad 400 mg (manufactured at Site 1)
干预措施: Lesinurad 400 mg (manufactured at Site 1) (Drug)
Sequence B
Day 1: Lesinurad 400 mg (manufactured at Site 2); Day 5: Lesinurad 400 mg (manufactured at Site 1)
干预措施: Lesinurad 400 mg (manufactured at Site 2) (Drug)
Sequence A
Day 1: Lesinurad 400 mg (manufactured at Site 1); Day 5: Lesinurad 400 mg (manufactured at Site 2)
干预措施: Lesinurad 400 mg (manufactured at Site 1) (Drug)
Sequence A
Day 1: Lesinurad 400 mg (manufactured at Site 1); Day 5: Lesinurad 400 mg (manufactured at Site 2)
干预措施: Lesinurad 400 mg (manufactured at Site 2) (Drug)
结局指标
主要结局
PK profile of lesinurad from plasma
时间窗: Day 1 and Day 5
PK endpoints in terms of maximum observed concentration (Cmax); time of occurrence of maximum observed concentration (tmax); area under the plasma concentration time curve from zero to 24 hours post dose (AUC last) and from zero to infinity (AUC ∞); and apparent terminal half-life (t1/2). Point estimates and 90% confidence intervals for the ratio of geometric means for Cmax, AUC last and AUC∞ between test and reference formulations.
次要结局
- Incidence of Adverse Events(5 weeks)