NCT03266705已完成1 期
A Phase 1, Open-label, Randomized, Crossover, Multiple Dose, Pivotal Bioequivalence Study To Compare Pf-06291826 4 X 20 Mg Tafamidis Meglumine And 61 Mga Tafamidis Free Acid Soft Gelatin Capsules Administered Under Fasted Conditions To Healthy Volunteers
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
- 30
- 试验地点
- 1
- 主要终点
- maximum observed plasma concentration (Cmax)
研究概览
简要总结
2 different formulations and doses of tafamidis will be compared. All subjects will receive both doses/formulations. Subjects will take tafamidis for 7 days, on the first 2 days they will take tafamidis twice, 12 hours apart and then once a day for the next 5 days. Subjects will be fasted before taking the drug. Blood samples will be taken to measure the amount of tafamidis starting on day 7 and ending on day 8. At least 16 days after the first formulation/dose is given, all subjects will repeat the procedure with the other formulation/dose.
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 of females of non-childbearing potential
- •Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
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.
- •Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer)
- •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
Experimental
干预措施: tafamidis (Drug)
4x20 mg tafamidis meglumine soft gelatin capsule
Experimental
干预措施: tafamidis (Drug)
结局指标
主要结局
maximum observed plasma concentration (Cmax)
时间窗: 24 hours
Area under the concentration-time curve (AUC)
时间窗: 24 hours
次要结局
- minimum observed plasma concentration (Cmin)(24 hours)
- Time to maximum observed plasma concentration (Tmax)(24 hours)
研究者
研究点 (1)
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