NCT01146041已完成1 期
Randomized, 2-Way Crossover, Bioequivalence Study of Rivastigmine 1.5 mg Capsules and Exelon Administered as 1 x 1.5 mg Capsule in Healthy Subjects Under Fed Conditions
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 主要终点
- Bioequivalence based on Cmax and AUC parameters
研究概览
简要总结
The purpose of this bioequivalence study is to compare the test of Rivastigmine 1.5 mg Capsules of Dr.Reddy's Laboratories Limited with reference to Exelon 1.5 mg of Novartis in Healthy Subjects Under Fed Conditions.
详细描述
Bioequivalence study of Rivastigmine Capsules 1.5 mg and Exelon 1.5 mg This was a single center, single-dose, open-label, randomized, 2-way crossover bioequivalence study,performed under fed conditions. The treatment phases were separated by a washout period of 7 days.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Rivastigmine
Experimental
Rivastigmine capsules 1.5 mg of Dr.Reddy's Laboratories Limited
干预措施: Rivastigmine (Drug)
exelon
Active Comparator
Exelon 1.5 mg capsules of Novartis
干预措施: Rivastigmine (Drug)
结局指标
主要结局
Bioequivalence based on Cmax and AUC parameters
时间窗: 3 months
次要结局
未报告次要终点
研究者
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