NCT01491503已完成1 期
Open Label, Randomized, 6-sequence Crossover Study to Evaluate the Drug-drug Interaction Between Montelukast Sodium and Levocetirizine Dihydrochloride in Health Male Volunteers
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011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
- 30
- 试验地点
- 1
- 主要终点
- AUClast
研究概览
简要总结
The purpose of this study is to evaluate the drug-drug interaction between montelukast sodium and levocetirizine dihydrochloride in healthy male volunteers.
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
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Healthy male
- •Age between 20 and 55
- •Signed informed consent
排除标准
- •Has a history of hypersensitivity to IP ingredients
- •Hypotension or hypertension
- •Has a history of acute infection within 14days of screening
研究组 & 干预措施
Montelukast and levocetirizine
Experimental
干预措施: Montelukast & levocetirizine (Drug)
Montelukast
Active Comparator
干预措施: montelukast sodium (Drug)
Levocetirizine
Active Comparator
干预措施: Levocetirizine (Drug)
结局指标
主要结局
AUClast
时间窗: 0-36hrs
Cmax
时间窗: 0-36hrs
次要结局
- Tmax(0-36hrs)
- T1/2(0-36hrs)
- AUCinf(0-36hrs)
研究者
研究点 (1)
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