NCT01351129
已完成
1 期
A Phase 1, Single-Dose, Open-Label, Crossover Study To Estimate The Relative Bioavailability Of Two Controlled-Release Formulations Vs. An Immediate Release Formulation Of PF-04991532 In Healthy Adult Subjects
概览
- 阶段
- 1 期
- 干预措施
- Formulation 1
- 疾病 / 适应症
- Healthy
- 发起方
- Pfizer
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time profile (AUC)
- 状态
- 已完成
- 最后更新
- 14年前
概览
简要总结
The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability three different formulations of PF-04991532 in healthy adult subjects.
研究者
入排标准
入选标准
- •Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive.
- •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.
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.
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
- •A positive urine drug screen.
研究组 & 干预措施
Formulation 1
干预措施: Formulation 1
Formulation 2
干预措施: Formulation 2
Formulation 3
干预措施: Formulation 3
结局指标
主要结局
Area under the plasma concentration versus time profile (AUC)
时间窗: predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose
次要结局
- Time of Cmax (Tmax)(predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose)
- Concentration at 24 hours postdose (C24hr)(24 hrs postdose)
- Max observed plasma concentration (Cmax)(predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose)
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Single Dose Study Of The Effect Of Cyclosporine On The Pharmacokinetics Of PF-04991532 In Health VolunteersHealthyDrug InteractionNCT01370343Pfizer12
已完成
1 期
Pharmacokinetics of Voxilaprevir in Adults With Normal Renal Function and Severe Renal ImpairmentHCV InfectionNCT02402452Gilead Sciences20
终止
1 期
A Three-part Study to Determine the Safety, Tolerability and Pharmacokinetics of GSK1322322 in Healthy Volunteers and Healthy Male Japanese SubjectsInfections, BacterialNCT01818011GlaxoSmithKline12
已完成
1 期
Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04991532Type 2 Diabetes MellitusHealthyNCT01369602Pfizer27
已完成
1 期
Pharmacokinetics of Voxilaprevir in Adults With Normal Hepatic Function and Moderate or Severe Hepatic ImpairmentHCV InfectionNCT02397707Gilead Sciences33