A Phase 1, Randomized, Open Label, Single Dose, 2 Period Crossover Study To Evaluate The Effect Of Food On The Pharmacokinetics Of Tofacitinib Modified Release (mr) 22 Mg Tablets In Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- AUC inf
研究概览
简要总结
This study will evaluate the drug behavior and safety of a single dose of the 22 milligram tofacitinib (CP-690,550) modified-release formulation in 18 healthy volunteers when taken after eating a high fat meal (the effect of food). This will be compared to the drug behavior and safety of a single dose of the 22 milligram tofacitinib (CP-690,550) modified-release formulation when taken after a 10 hour fast.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers and/or healthy female volunteers of non-childbearing potential who are 18 to 55 years of age;
- •Healthy volunteers with no evidence of active or latent or inadequately treated tuberculosis.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
- •Clinically significant infections within the past 3 months
研究组 & 干预措施
Tofacitinib MR 22 mg Fed
Single dose of tofacitinib MR 22 mg administered under fed conditions
干预措施: Tofacitinib MR 22 mg (Fed) (Drug)
Tofacitinib MR 22 mg Fasted
Single dose of tofacitinib MR 22 mg administered under fasted conditions
干预措施: Tofacitinib MR 22 mg (Fasted) (Drug)
结局指标
主要结局
AUC inf
时间窗: 48 hours post dose
Area under the plasma concentration-time profile from time zero to infinity (AUCinf).
AUC last
时间窗: 48 hours post dose
Area under the plasma concentration-time profile from time zero to time of last identifiable quantitation (AUC last).
Cmax
时间窗: 48 hours post dose
Maximum observed plasma concentration (Cmax).
次要结局
- Plasma Decay Half-Life (t 1/2)(48 hours post dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(48 hours post dose)