NCT01342055已完成1 期
Phase I Study of Apetrol ES and Megace® in Healthy Male Volunteers
LG Life Sciences1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2011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
- 38
- 试验地点
- 1
- 主要终点
- Cmax, AUClast
研究概览
简要总结
A Randomized, Open Label, Single dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of Apetrol ES and Megace® under Fed Conditions 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
- •Is a healty male between 20 and 55 years old
- •Has BMI result between 19 and 26 kg/m2 at screening
- •Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- •Agrees to use an adequate means of contraception during clinical trials
排除标准
- •Has had a serious illness or medical condition(s) regarding liver, kidney, gastrointestines, pulmonary systems, etc.
- •Has had a medical history of gastrointestinal diseases which might affect drug absorption (i.e. Crohn's disease, ulcer) or surgical history.
- •Is allergic against Megestrol acetate or other drugs (Aspirin, NSAIDs, Antibiotics, etc.) or against foods, or has an clinically serious allergic history
研究组 & 干预措施
Group 1 : Megace 800mg - Apetrol ES 650mg - Apetrol ES 675mg
Experimental
干预措施: Apetrol ES (Drug)
Group 2 : Apetrol ES 650mg - Apetrol ES 675mg -Megace 800mg
Experimental
干预措施: Apetrol ES (Drug)
Group 4: Megace 800mg - Apetrol ES 675mg - Apetrol ES 650mg
Experimental
干预措施: Apetrol ES (Drug)
Group 5: Apetrol ES 650mg - Megace 800mg - Apetrol ES 675mg
Experimental
干预措施: Apetrol ES (Drug)
Group 3: Apetrol ES 675mg - Apetrol ES 650mg - Megace 800mg
Experimental
干预措施: Apetrol ES (Drug)
Group 6 : Apetrol ES 675mg - Megace 800mg - Apetrol ES 650mg
Experimental
干预措施: Apetrol ES (Drug)
结局指标
主要结局
Cmax, AUClast
时间窗: Day 34
次要结局
- AUCinf, Tmax, t1/2(beta)(Day 34)
研究者
研究点 (1)
Loading locations...
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