NCT01568450已完成1 期
A Randomized, Open-label, Single-dose, Crossover Study to Investigate The Pharmacokinetics Between a GL2907 XL and Oxycontin CR Tab. 10mg in Healthy Male Volunteers
GL Pharm Tech Corporation1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2012年3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
- 24
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GL2907 XL 20mg tablet and Oxycontin CR 10mg tablet.
GL2907 XL 20mg tablet is controlled released formulation which is made by GL Pharm Tech.
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
- •≥ 50kg(Body Weight) and Ideal Body Weight ≤ ±20%
排除标准
- •ALT or AST > 1.25(Upper Normal Range)
- •Total Bilirubin > 1.5 (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
GL2907 XL 20mg (Oxycodone 20mg, fasted)
Experimental
干预措施: Oxycodone (Drug)
GL2907 XL 20mg (Oxycodone 20mg, after high fat meal)
Experimental
干预措施: Oxycodone (Drug)
Oxycontin CR 10mg (Oxycodone 10mg, fasted)
Active Comparator
干预措施: Oxycodone (Drug)
结局指标
主要结局
Cmax
时间窗: 48hr
Pharmacokinetic of Oxycodone
AUC(0-24h)
时间窗: 24 hr
Pharmacokinetic of Oxycodone
次要结局
- Tmax(48 hr)
- t1/2(48 hr)
- Vz/F(48 hr)
- CL/F(48 hr)
- Safety Monitoring(27 days)
研究者
研究点 (1)
Loading locations...
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