NCT01521455已完成1 期
A Phase I, Randomized, Open, Multi-center, Cross Over Study to Evaluate the Therapeutic Equivalence of Repeated Dose of HCP0910 250/50 μg to SeretideTM 250 DiskusTM in Asthmatic Patients
Hanmi Pharmaceutical Company Limited7 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2012年2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
- 56
- 试验地点
- 7
- 主要终点
- mean change of morning predose FEV1 from baseline
研究概览
简要总结
The purpose of this study is to prove that HCP0910 is therapeutically equivalent to Seretide 250 Diskus when repeatedly dosed to Asthmatic patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 20 ~ 75 inclusive
- •Asthmatic diagnosis in more than 12 weeks from screening day
- •Shows more than 12 % increase, and 200mL increase in FEV1 measure on Visit 2
排除标准
- •Maintain controlled asthma for more than 4 weeks before screening
- •Diagnosed as a severe asthmatic patients
研究组 & 干预措施
HCP0910
Experimental
Fluticasone /salmeterol 250/50 combination capsule
干预措施: HCP0910 (Drug)
Seretide Diskus
Active Comparator
Seretide 250 Diskus
干预措施: Seretide Diskus (Drug)
结局指标
主要结局
mean change of morning predose FEV1 from baseline
时间窗: day 14
次要结局
未报告次要终点
研究者
研究点 (7)
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