NCT01197014已完成1 期
A Single-dose, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Bioequivalence Study of Amlodipine and Losartan Versus Two Co-administration of Amlodipine and Losartan in Healthy Caucasian Subjects
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2010年9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
- 72
- 试验地点
- 1
- 主要终点
- AUC, Cmax
研究概览
简要总结
Study Design :
- A single center, open, randomized, single dose, two-period, two-treatment, two-sequence, crossover study
详细描述
Primary Objective:
- To assess the bioequivalence of combination oral formulation of amlodipine/losartan versus two co-administered products containing amlodipine and losartan
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Age 18-55 years
- •Healthy Caucasian volunteers
- •Non smokers or mild smokers
- •Exclusion criteria:
- •Pregnancy and/or breast-feeding
- •Participation in another clinical trial within 60 days prior to Period 1
排除标准
- 未提供
研究组 & 干预措施
Amlodipine, Losartan
Active Comparator
干预措施: Amlodipine, Losartan (Drug)
Amlodipine plus Losartan
Experimental
干预措施: Amlodipine plus Losartan (Drug)
结局指标
主要结局
AUC, Cmax
时间窗: 0-144hrs
次要结局
未报告次要终点
研究者
研究点 (1)
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