NCT02406560已完成1 期
A Phase 1, Open-label, Randomized, Crossover, Oral, Single Dose Study To Estimate The Relative Bioavailability Of Pf-06291826 (Tafamidis) Following Administration Of A Tafamidis Free Acid Tablet Formulation In Healthy Subjects Under Fasted And Fed 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
- 12
- 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 either a high fat meal or while fasted. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for one week. After about 14 days, subjects will take either a different dose of tafamidis or the same dose under the opposite meal condition. Tafamidis concentrations from the three different conditions 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 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
4 tablets of 12.2 mg tafamdis free acid
Experimental
干预措施: tafamidis (Drug)
4 tablets of 12.2 mg tafamidis free acid
Experimental
干预措施: tafamidis (Drug)
5 tablets of 12.2 mg tafamidis free acid
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
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(168 hours)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(168 hours)
- Plasma Decay Half-Life (t1/2)(168 hours)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study To Estimate How Much Tafamidis Created In Different Ways Can Be Measured in Blood SamplesHealthy VolunteersNCT02189330Pfizer24
已完成
1 期
A Bioequivalence Study Comparing Two Different Tafamidis FormulationsHealthy VolunteersNCT02217813Pfizer26
已完成
1 期
A Study Comparing Amounts of Tafamidis (PF-06291826) in the Blood Without Food in Healthy VolunteersHealthyNCT02746926Pfizer12
已完成
1 期
A Study Comparing Amounts of Tafamidis In The Blood Without FoodHealthyNCT02697864Pfizer12
已完成
1 期
A Study Comparing the Amounts of 2 Different Forms of Tafamidis (PF06291826), Both With and Without Food, In the BloodHealthyNCT03280173Pfizer18