NCT03871439已完成1 期
A PHASE 1, OPEN LABEL, TWO-PERIOD, RANDOMIZED CROSSOVER STUDY TO COMPARE THE PHARMACOKINETICS OF TWO DIFFERENT FORMULATIONS OF PF-05221304 ADMINISTERED ORALLY TO HEALTHY ADULT SUBJECTS
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
- 10
- 试验地点
- 1
- 主要终点
- Plasma PF-05221304 AUClast
研究概览
简要总结
The purpose of this study is to characterize the plasma pharmacokinetics of two formulations of PF 05221304 in healthy adults.
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
- •Ages of 18 and 55 years old inclusive
- •Body Mass Index (BMI) of >= 17.5 and <= 30.4 kg/m2
- •Total body weight > 50 kg (110lb)
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, allergic disease or clinical findings
研究组 & 干预措施
PF-05221304 Formulation A
Experimental
干预措施: PF-05221304 Formulation A (Drug)
PF-05221304 Formulation B
Experimental
干预措施: PF-05221304 Formulation B (Drug)
结局指标
主要结局
Plasma PF-05221304 AUClast
时间窗: Thirteen timepoints between 0-72 Hours
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Plasma PF-05221304 Cmax
时间窗: Thirteen timepoints between 0-72 Hours
Maximum Observed Plasma Concentration (Cmax)
次要结局
- Number of Subjects Experiencing an Adverse Event(Up to 10 weeks from screening)
- Number of Participants With Clinical Laboratory Abnormalities(Up to 10 weeks from screening)
- Number of Participants With Categorical Vital Signs Data(Up to 10 weeks from screening)
- Number of Participants With Abnormal Electrocardiogram (ECG)(Up to 10 weeks from screening)
研究者
研究点 (1)
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