NCT00602134已完成不适用
A Pharmacokinetic Study to Assess the Single-Dose Bioequivalence of a Potential Generic Formulation of a 6-Mercaptopurine 50 mg Tablet Compared to a Marketed 6-Mercaptopurine 50 mg Tablet, Purinethol®, When Administered to Healthy Male Subjects, in the Fasted State
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Bioequivalence
研究概览
简要总结
The objective of this study was to assess the bioequivalence of a potential generic 6-mercaptopurine 50 mg tablet formulation compared with GlaxoSmithKline Purinethol® (mercaptopurine) 50-mg scored tablets following a single 50 mg oral dose administered in the fasted state.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •No clinically significant abnormal findings on physical examination, medical history, or clinical laboratory results.
- •Must voluntarily consent.
排除标准
- •Must not have a known history of thiopurine methyltransferase deficiency or family history.
- •Must not have a history of elevated uric acid or gout.
- •Must not be currently using allopurinol.
结局指标
主要结局
Bioequivalence
时间窗: Baseline, two period, 3 day washout
次要结局
未报告次要终点
研究者
研究点 (2)
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