NCT00668967已完成1 期
Bioequivalence Study Of Verapamil (Covera HS) 240 Mg Extended Release Tablets Produced By Alza Corporation, Vacaville And Pfizer Inc, Puerto Rico: A Two Sequence, Four-Way Crossover Design, Single Dose, Open-Label, Randomized Study In Healthy Volunteers
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
- 79
- 试验地点
- 1
- 主要终点
- Primary study endpoints will be AUClast, AUCinf and Cmax of R- and S-verapamil.
研究概览
简要总结
The purpose of this study is to demonstrate bioequivalence of single doses of two verapamil formulations
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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 screen
研究组 & 干预措施
Reference
Other
marketed extended release verapamil tablet
干预措施: verapamil (Drug)
Test
Other
reformulated extended release verapamil tablet
干预措施: verapamil (Drug)
结局指标
主要结局
Primary study endpoints will be AUClast, AUCinf and Cmax of R- and S-verapamil.
时间窗: 5 months
次要结局
- Secondary endpoints will include Tmax and t1/2 of R- and S-verapamil and S- and R- norverapamil, as data permit. AUClast, AUCinf and Cmax of R- and S-norverapamil as data permit.(5 months)
- Safety and tolerability as assessed by reported adverse events, safety lab test and vital signs(5 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Food Study of Verapamil HCl Extended-Release Capsules 300 mg and Verelan® PM Extended-Release Capsules 300 mgHealthyNCT00648401Mylan Pharmaceuticals Inc24
已完成
1 期
Comparative Bioavailability Study of Synerx and Verelan PM 300 mg Verapamil HCl ER Capsules Under Fed ConditionsHealthyNCT01467687Synerx Pharma, LLC58
已完成
1 期
Fasting Study of Verapamil HCl Extended-Release Capsules 300 mg to Verelan® PM Extended-Release Capsules 300 mgHealthyNCT00648050Mylan Pharmaceuticals Inc72
已完成
1 期
Fasting Study of Verapamil HCl Extended-Release Capsules 300 mg and Verelan® PM Extended-Release Capsules 300 mgHealthyNCT00647673Mylan Pharmaceuticals Inc24
已完成
1 期
Fasting Applesauce Study of Verapamil HCl Extended-Release Capsules 300 mg and Verelan® PM Extended-Release Capsules 300 mgHealthyNCT00649805Mylan Pharmaceuticals Inc24