NCT01651481已完成1 期
Open-label, Randomized, Single Dose Crossover Study to Evaluate the Pharmacokinetics and Safety of Singulair (10 mg) and Xyzal (5 mg) in Free Combination and Fixed-dose Combination as HCP1102 in Healthy Male Volunteers
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2012年7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
- 28
- 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 pharmacokinetics and safety of Singulair (10 mg) and Xyzal (5 mg) in free combination and fixed-dose combination as HCP1102
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
- 是
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 14 days of screening
研究组 & 干预措施
TR
Experimental
HCP1102(Singulair and Xyzal combination tablet) -> coadministration of Singulair and Xyzal
干预措施: HCP1102 (Drug)
TR
Experimental
HCP1102(Singulair and Xyzal combination tablet) -> coadministration of Singulair and Xyzal
干预措施: Singulair and Xyzal (Drug)
RT
Experimental
coadministration of Singulair and Xyzal -> HCP1102(Singulair and Xyzal combination tablet)
干预措施: HCP1102 (Drug)
RT
Experimental
coadministration of Singulair and Xyzal -> HCP1102(Singulair and Xyzal combination tablet)
干预措施: Singulair and Xyzal (Drug)
结局指标
主要结局
AUClast
时间窗: 0-34hr
Cmax
时间窗: 0-34hr
次要结局
- tmax(0-34hr)
- AUCinf(0-34hr)
- t1/2(0-34hr)
研究者
研究点 (1)
Loading locations...
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