A Phase 1, Open-Label, Randomized, 2-Cohort, Crossover, Single Dose Study to Estimate the Relative Bioavailability of PF 06291826 (Tafamidis) Following Administration of Two Oral Formulations Versus Commercial Capsule in Healthy Subjects Under Fasted Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
研究概览
简要总结
All subjects in this study will be given tafamidis. After swallowing a single pill of tafamidis, measurements including blood samples will be compared to see if tafamidis made in different ways is about the same. After approximately 28 days subjects will be given another pill of tafamidis and the study measurements will be repeated.
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 males or females of non-child bearing potential.
- •Body Mass Index (BMI) of 17.5 to 30.5 and total body weight more than 50 kg (110 lbs).
排除标准
- •Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg (diastolic).
- •Use of prescription or nonprescription drugs supplements within 7 days prior to 7 days of the study.
研究组 & 干预措施
Tafamidis
干预措施: Tafamidis (Drug)
Tafamudus Free Acid
干预措施: Tafamidis (Drug)
20 mg new soft gelatin capsule
干预措施: Tafamidis (Drug)
4 capsules of 20 mg tafamidis of commercial formulation
干预措施: Tafamidis (Drug)
4 capsules of 12.2 mg tafamidis of free acid tablet
干预措施: Tafamidis (Drug)
结局指标
主要结局
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
时间窗: 168 hours
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Maximum Observed Plasma Concentration (Cmax)
时间窗: 168 hours
次要结局
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(168 hours)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(6)