An Open Label, Single Dose, Randomized 2-Way Crossover Study To Estimate The Relative Bioavailability Of Atorvastatin Commercial Tablet, And An Extemporaneous Preparation (EP) Suspension Formulation, In Healthy Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax)
研究概览
简要总结
The purpose of this study is to estimate the relative bioavailability of the commercial tablet with one prototype extemporaneous preparation suspension formulation, to assist with internal decision making on formulation development.
详细描述
Estimation of Relative Bioavailability
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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 subjects
- •Body Mass Index (BMI) of approximately 18 to 30 kg/m2
排除标准
- •Any condition possibly affecting drug absorption
- •A positive urine drug screening
研究组 & 干预措施
Test
Extemporaneous preparation suspension Atorvastatin prototype formulation
干预措施: Atorvastatin suspension (Drug)
Reference
Commercial atorvastatin tablet (Lipitor®)
干预措施: Lipitor (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax)
时间窗: 5 days
Geometric mean of Cmax = maximum observed plasma concentration of atorvastatin (test vs reference); measured in nanograms per milliliter (ng/mL).
Area Under the Curve From Predose (Time Zero) to 48 Hours Post-dose (AUC48)
时间窗: 5 days
Geometric means of AUC48 = area under the plasma concentration-time profile from time zero (0) to 48 hours postdose of atorvastatin (test versus \[vs\] reference); measured in nanograms times hour per milliliter (ng.hr/mL).
Area Under the Curve From Predose (Time Zero) to Extrapolated Infinite Time (AUC Infinity)
时间窗: 5 days
Geometric means of AUC infinity (AUCinf) = area under the plasma concentration-time curve from time zero (0) extrapolated to infinite time; measured in ng.hr/mL of atorvastatin (test vs reference).
次要结局
- Area Under the Curve From Predose (Time Zero) to Last Quantifiable Concentration (AUClast)(5 days)
- Terminal Phase Rate Constant (Kel)(5 days)
- Time to Reach Maximum Plasma Concentration (Tmax)(5 days)
- Plasma Elimination Half-life (t1/2)(5 days)