NCT01653314已完成1 期
A Randomized, Open-label, Single Dose, 2-Treatment, 2-Period, 2-Way Crossover Study to Assess Safety and Pharmacokinetics of Megavec 400 mg (Imatinib Mesylate) Under Fasted Conditions in Healthy Male Subjects
Daewoong Pharmaceutical Co. LTD.0 个研究点目标入组 40 人开始时间: 2012年1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
- 40
- 主要终点
- Safety
研究概览
简要总结
The purpose of this Study is to Assess Safety and Pharmacokinetics of megavec 400 mg (Imatinib mesylate) under Fasted Conditions in Healthy Male Subjects.
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
- Double (Participant, Investigator)
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 and male subjects aged 20 to 55 years
- •The subject has a Body weight ≥55 kg and ideal body weight (IBW) within ±20%
- •A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)
- •A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints.
排除标准
- •A subject with sign or symptoms or previously diagnosed disease of respiratory, cardiovascular, endocrinology, liver, kidney, hematology, neurology and psychology function or other significant diseases and history
- •Known allergy or hypersensitivity to the study medication
- •AST or ALT greater than 1.25 times the upper limit of reference range or Total bilirubin greater than 1.25 times the upper limit of reference range base on screening results
- •A subject judged ineligible by the investigator to participate in this study for other reason containing clinical laboratory tests
研究组 & 干预措施
Megavec
Experimental
干预措施: Megavec (Drug)
Megavec
Experimental
干预措施: Glivec (Drug)
Glivec
Active Comparator
干预措施: Megavec (Drug)
Glivec
Active Comparator
干预措施: Glivec (Drug)
结局指标
主要结局
Safety
Adverse events, Physical exam, Vital sign, Laboratory, 12-lead-ECG
次要结局
- Pharmacokinetics
研究者
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