跳至主要内容
临床试验/NCT03280173
NCT03280173已完成1 期

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

Pfizer1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2017年9月29日最近更新:
适应症
干预措施

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

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

Experimental

fasted

干预措施: tafamidis (Drug)

61 mgA tafamidis free acid soft gelatin capsule fasted

Experimental

fed

干预措施: tafamidis (Drug)

4 × 20 mg tafamidis meglumine soft gelatin capsules fed

Experimental

fed

干预措施: tafamidis (Drug)

4 × 20 mg tafamidis meglumine soft gelatin capsules fasted

Experimental

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)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验