NCT01388829已完成1 期
A Phase 1, Single-Dose, Open-Label, Crossover Study To Assess The Relative Bioavailability Of 2 Different Formulations Of PF-04991532
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 AUClast
研究概览
简要总结
This study is designed to compare the pharmacokinetics of two different lots of tablets.
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 male and/or female (non childbearing potential) subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests. Women must be of non childbearing potential as defined in Lifestyle Guidelines.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- •An informed consent document signed and dated by the subject or a legally acceptable representative.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
- •Screening supine blood pressure 140 mm Hg (systolic) or 90 mm Hg (diastolic), on a single measurement [confirmed by a single repeat, if necessary] following at least 5 minutes of rest.
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
研究组 & 干预措施
formulation comparison
Experimental
formulation comparison
干预措施: Treatment A (Drug)
formulation comparison
Experimental
formulation comparison
干预措施: Treatment B (Drug)
结局指标
主要结局
Plasma AUClast
时间窗: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours
Plasma Cmax
时间窗: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours
次要结局
- Plasma Tmax(0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Compare the Relative Bioavailability of Two AG-881 Formulations and Evaluate the Effect of Food and Omeprazole on the Pharmacokinetics of AG-881Healthy VolunteersNCT04128787Agios Pharmaceuticals, Inc.36
已完成
1 期
A Phase 1 Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial+Syringe Presentation in Healthy AdultsBioequivalenceNCT05817435argenx120
已完成
1 期
Clinical Trial of Efepoetin Alfa in Healthy SubjectsHealthyNCT06490939Genexine, Inc.40
已完成
1 期
India Dexamethasone and BetamethasonePreterm BirthAntenatal CorticosteroidsNCT03668860Children's Hospital Medical Center, Cincinnati48
已完成
1 期
The PK Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 in Healthy Male VolunteersDiabetesHyperlipidemiaNCT02982798Jeil Pharmaceutical Co., Ltd.40