KCT0000755已完成未知
Open-label, randomized, single-dose, 2-way crossover study to evaluate the pharmacokinetics of CJ Imatinib mesylate tablet 1 x 200mg compared with Gleevec film-coated tablet 2 x 100mg in healthy male volunteers
CJ CheilJedang0 个研究点目标入组 28 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 55(Year)（—）
- 性别
- Male
入选标准
- •1)Healthy male of 20 to 55 years of age
- •2)18.5 kg/m2 = BMI = 27 kg/m2
- •3)A subject who is able to participate whole periods of the study
- •4)A subject who provides written informed consent voluntarily
排除标准
- •1)Systolic blood pressure < 90 or = 140 mmHg, diastolic blood pressure < 60 or = 90 mmHg, or pulse rate >100 beats per minute
- •2)History of hypersensitivity to the investigational products or to drugs
- •3)One of the following values in the clinical laboratory test
- •- AST, ALT, or bilirubin upper than 1.5 times the upper range of normal
- •- Glomerular filtration rate using MDRD formula less than 80 mL/min
- •4)Use of the drug which induces or inhibits CYP3A within 30 days before the first investigational product administration
- •5)Use of caffeine-containing beverages (coffee, tea, or coke), grapefruit or orange juice more than 4 cups a day
- •6)Smoking more than 20 cigarettes per day
- •7)Use of alcohol more than 140 g per week (12° wine 1 glass (125 mL) = 12.0 g, 4° beer 1 glass (250 mL) = 8 g, 20° soju 0.5 bottle (180 mL) = 28.8 g)
研究者
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