NCT00777517已完成1 期
An Open Label, Randomized, Single Dose, Two-Way Crossover Bioequivalence Study Comparing A Pediatric Appropriate Formulation To A 10 Mg Commercial Atorvastatin Calcium Tablet Formulation In Healthy Subjects
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2008年11月最近更新:
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
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Primary study endpoints will be AUClast, AUCinf (if data permit) and Cmax from plasma atorvastatin concentration data.
研究概览
简要总结
To determine bioequivalence of a atorvastatin pediatric formulation comparing to the 10 mg commercial atorvastatin calcium tablet formulation.
详细描述
Determination of Bioequivalence
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
- •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
Reference
Other
Commercial 10 mg Lipitor formulation tablet
干预措施: Lipitor (Drug)
Test
Other
Atorvastatin pediatric formulation
干预措施: Atorvastatin pediatric formulation (Drug)
结局指标
主要结局
Primary study endpoints will be AUClast, AUCinf (if data permit) and Cmax from plasma atorvastatin concentration data.
时间窗: 5 months
次要结局
- Secondary endpoints will include Tmax and t1/2 (if data permit) of atorvastatin ; AUClast, AUCinf, Cmax, Tmax, and t1/2 (if data permit) of o-hydroxyatorvastatin and p-hydroxyatorvastatin.(5 months)
研究者
研究点 (1)
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