IRCT20200407046981N4招募中未知
Randomized, single-dose, crossover comparative bioequivalence study of the Imatinib 100 mg capsules produced by Kimia pharmaceutical Co versus Gleveec® (NOVARTIS company) in 18 healthy males under fasting conditions
Kimia pharmaceutical Co0 个研究点目标入组 18 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 60 years（—）
- 性别
- Male
入选标准
- •The weight limit for each volunteer is between 60 and 100 kg.
- •Only non-smokers are allowed to participate.
- •They must be healthy in terms of liver and kidney status, respiratory system, and other general health characteristics that will be assessed.
排除标准
- •Known hypersensitivity or idiosyncratic reaction to Imatinib or any ingredients.
- •Subjects with BP = 90/60 mm/Hg or BP = 140/90 mm/Hg Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function or a history of TB, epilepsy, asthma (during past 5 years), DM, psychosis or glaucoma.
- •Regular smoker who smokes more than ten cigarettes daily.
- •Taking any medicine during two week before dosing.
研究者
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