A Phase 1, Open-label, Randomized, Four-period, Four-sequence, Single-dose, Crossover Study In Healthy Volunteers, To Determine The Relative Bioavailability Of Pf-06291826 61 Mga Tafamidis Free Acid Soft Gelatin Capsules Compared To Commercial 4 × 20 Mg Tafamidis Meglumine Soft Gelatin Capsules Administered Under Fasted And Fed Conditions And The Effect Of Food On The Oral Bioavailability Of Pf-06291826 61 Mga Tafamidis Free Acid Soft Gelatin Capsules
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
- Area under the concentration-time curve 0-72 hours (AUC72)
研究概览
简要总结
2 different formulations of tafamidis will be compared under both fed and fasted conditions. Subjects will be fasted overnight or fed. After swallowing one of the tafamidis formulations, tafamidis blood concentrations will be measured periodically for 8 days. After 16 days, subjects will take a different formulation in the fed or fasted state or take the same formulation in the opposite feeding condition. This will be repeated, 16 days apart, until all subjects have taken each formulation both fed and fasted.
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.
- •Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception.
研究组 & 干预措施
61 mgA tafamidis free acid soft gelatin capsule fed
fasted
干预措施: tafamidis (Drug)
61 mgA tafamidis free acid soft gelatin capsule fasted
fed
干预措施: tafamidis (Drug)
4 × 20 mg tafamidis meglumine soft gelatin capsules fed
fed
干预措施: tafamidis (Drug)
4 × 20 mg tafamidis meglumine soft gelatin capsules fasted
fasted
干预措施: tafamidis (Drug)
结局指标
主要结局
Area under the concentration-time curve 0-72 hours (AUC72)
时间窗: 72 hrs
maximum observed plasma concentration (Cmax)
时间窗: 168 hrs
次要结局
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(168 hrs)
- Mean residence time (MRT)(168 hrs)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(168 hrs)
- Plasma Decay Half-Life (t1/2)(168 hrs)
- Area under the curve from zero to infinity (AUCinf)(168 hrs)
