NCT00758004已完成1 期
An Open Label, Randomized, Single Dose, Two-Way Crossover Bioequivalence Study Comparing A New 80 Mg (2x40 mg) Pediatric Appropriate Formulation To A 80 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10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 pediatric appropriate 80 mg atorvastatin formulation comparing to the 80 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 volunteers
- •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 80 mg atorvastatin tablet
干预措施: Atorvastatin (Drug)
Test
Other
Pediatric appropriate atorvastatin 40mg formulation
干预措施: Atorvastatin pediatric appropriate 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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