NCT01864863已完成1 期
An Open-label, Randomized, Single-dose, 2-way Crossover Study to Compare the Pharmacokinetics of Traclear 62.5 mg 2 Tablets and HGP1206 125mg 1 Tablet 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: 2013年4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 compare the pharmacokinetics of two Traclear 62.5 mg tablets and one HGP1206 125 mg tablet in healthy male volunteers.
详细描述
An Open-label, Randomized, Single-dose, 2-way Crossover Study to Compare the Pharmacokinetics and safety of Traclear 62.5 mg Tablets and HGP1206 125mg Tablet 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
- 是
入选标准
- •Healthy male
- •Age between 20 and 55
- •Signed informed consent
排除标准
- •Has a history of Primary pulmonary hypertension to investigational product ingredients
- •Hypotension or hypertension
研究组 & 干预措施
Reference→Test
Experimental
Traclear 62.5 mg 2 tablets → HGP1206 125 mg 1 tablet
干预措施: Traclear (Drug)
Test→Reference
Experimental
HGP1206 125 mg 1 tablet → Traclear 62.5 mg 2 tablets
干预措施: HGP1206 (Drug)
Test→Reference
Experimental
HGP1206 125 mg 1 tablet → Traclear 62.5 mg 2 tablets
干预措施: Traclear (Drug)
Reference→Test
Experimental
Traclear 62.5 mg 2 tablets → HGP1206 125 mg 1 tablet
干预措施: HGP1206 (Drug)
结局指标
主要结局
AUClast
时间窗: 0-24h
Cmax
时间窗: 0-24h
次要结局
- Tmax(0~24h)
- AUCinf(0~24h)
- t1/2(0~24h)
研究者
研究点 (1)
Loading locations...
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