NCT02072213已完成1 期
A Randomized, Open-label, Single-dose, Four-sequence, Four -Period Crossover Study to Investigate The Pharmacokinetics of GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male Volunteers
GL Pharm Tech Corporation1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2013年8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
- 36
- 试验地点
- 1
- 主要终点
- AUClast
研究概览
简要总结
Study to Investigate The Pharmacokinetics of GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male Volunteers
详细描述
GL2702 GLARS-NF1 tablet is controlled released formulation which is invented by GL Pharm Tech Corp.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •20~45 years old, Healthy Adult Male Subject
- •Body Weight ≥ 50kg and Ideal Body Weight ≤ ±20%
排除标准
- •ALT or AST > 1.25 times (Upper Normal Range)
- •Total Bilirubin > 1.5 times (Upper Normal Range)
- •CPK > 2 times (Upper Normal Range)
- •BUN or Creatinine > Normal Range
- •Systolic BP > 160mmHg or < 80mmHg, Diastolic BP > 100mmHg or < 50mmHg
研究组 & 干预措施
GL2702 GLARS-NF1 , fasted
Experimental
Tamsulsoin 0.4mg
干预措施: GL2702 GLARS-NF1 (Drug)
Omix Ocas® , fasted
Active Comparator
Tamsulsoin 0.4mg
干预措施: Omix Ocas (Drug)
GL2702 GLARS-NF1, after meal
Experimental
Tamsulsoin 0.4mg
干预措施: GL2702 GLARS-NF1 (Drug)
Omix Ocas®, after meal
Active Comparator
Tamsulsoin 0.4mg
干预措施: Omix Ocas (Drug)
结局指标
主要结局
AUClast
时间窗: 48 hours
Pharmacokinetic parameter of Tamsulosin 0.4mg
Cmax
时间窗: 48 hours
Pharmacokinetic parameter of tamsulosin 0.4mg
次要结局
- CL/F(48 hours)
- Tmax(48 hours)
- t1/2(48 hours)
- Vz/F(48 hours)
研究者
研究点 (1)
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