NCT01599377已完成1 期
Phase 1, Open-Label, Randomized, Single-Dose, Cross-Over, Bioequivalence Study Comparing Tablets (5 And 10 Mg) And Capsules (5 And 10 Mg) Of Tofacitinib Under Fasted Conditions In Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax)
研究概览
简要总结
The overall aim of the study is to establish bioequivalence between commercial tofacitinib tablet formulations with the tofacitinib capsule formulation.
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
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including oral temperature, BP and PR measurement, 12 Lead ECG and clinical laboratory tests.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
研究组 & 干预措施
Cohort 1
Experimental
干预措施: tofacitinib 10 mg (Drug)
Cohort 2
Experimental
干预措施: tofacitinib 5 mg (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax)
时间窗: 24 hours
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf )
时间窗: 24 hours
次要结局
- Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)(24 hours)
- Time for Cmax (Tmax)(24 hours)
- Terminal elimination half-life (t½)(24 hours)
研究者
研究点 (1)
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