NCT02217813已完成1 期
A Phase 1, Open-label, Randomized, Crossover, Single Dose Study To Determine The Bioequivalence Of Pf-06291826 (Tafamidis) 20 Mg Capsule Manufactured By Catalent Versus Capsule Manufactured By Pii In Healthy Subjects Under Fasted Conditions
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
- 26
- 试验地点
- 1
- 主要终点
- Area under the Concentration-Time Curve (AUC)
研究概览
简要总结
Each subject will be given tafamidis. After swallowing a single tafamidis capsule, tafamidis blood concentrations will be measured periodically for one week. After about 20 days, subjects will take a different form of tafamidis capsule and the process repeated. Tafamidis concentrations from the two different formulations will be compared to determine if they are approximately the same.
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 Kg and total body weight more than 50 Kg (110 lbs).
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication.
研究组 & 干预措施
1. Tafamidis
Experimental
干预措施: Tafamidis (Drug)
2. Tafamidis
Experimental
干预措施: Tafamidis (Drug)
结局指标
主要结局
Area under the Concentration-Time Curve (AUC)
时间窗: 168 hours
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Maximum Observed Plasma Concentration (Cmax)
时间窗: 168 hours
次要结局
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(168 hours)
- Plasma Decay Half-Life (t1/2)(168 hours)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(168 hours)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)](168 hours)
研究者
研究点 (1)
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