A Randomized, Open-label, Single-dose, Crossover Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400 mg (1 Tablet) and Glivec Film-coated Tablet 100 mg (4 Tablets) After Oral Administration in Healthy Male Subjects (Phase I)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Maximum concentration in plasma (Cmax) of Imatinib mesylate
研究概览
简要总结
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Investigational Product
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Imatinib mesylate tablet 400 mg
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Glivec film-coated tablet 100 mg (Comparator)
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Expected target disease
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chronic myeloid leukemia
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Gastrointestinal stromal tumors
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Study design : Randomized, open-label, single dose, two-period, two-way, crossover study
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36 healthy subjects, 2 groups (18 subjects/group)
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2 Period (either 1-a(1 tablet) or 1-b(4 tablet))
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wash-out period : 14 days
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Evaluation on pharmacokinetics(PKs) and safety
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PKs : Cmax, AUClast, Tmax, AUCinf, t1/2
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safety : adverse events, physical examination, vital sign, ECG, Laboratory test
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Statistical method
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Demography Characteristics
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Pharmacokinetic parameters
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Safety data
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy male volunteers between the ages of 20 to 50 years old
- •weight more than 55kg and within the range of ±20% of ideal body weight (IBW)
- •having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
- •doctor determines to be suitable as subjects within 3 weeks ago before administration
排除标准
- •Hypersensitivity(or history of hypersensitivity) to medicines including imatinib mesylate
- •Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT, total bilirubin
- •Creatinine clearance < 80 mL/min
- •Gastrointestinal diseases or surgeries that affect absorption of drug
- •Excessive drinking(exceed 21units/week)
- •Smoking over 10 cigarettes per day
研究组 & 干预措施
Group 1 (RT)
- Period 1: Glivec film-coated tablet 100 mg, 4 tablets (Active comparator)
- Period 2: Imatinib mesylate tablet 400 mg, 1 tablet (experimental)
干预措施: Imatinib mesylate tablet 400 mg, 1 Tablet (Drug)
Group 1 (RT)
- Period 1: Glivec film-coated tablet 100 mg, 4 tablets (Active comparator)
- Period 2: Imatinib mesylate tablet 400 mg, 1 tablet (experimental)
干预措施: Glivec film-coated tablet 100 mg, 4 Tablets (Drug)
Group 2 (TR)
- Period 1: Imatinib mesylate tablet 400 mg, 1 tablet (experimental)
- Period 2: Glivec film-coated tablet 100 mg, 4 tablets (Active comparator)
干预措施: Imatinib mesylate tablet 400 mg, 1 Tablet (Drug)
Group 2 (TR)
- Period 1: Imatinib mesylate tablet 400 mg, 1 tablet (experimental)
- Period 2: Glivec film-coated tablet 100 mg, 4 tablets (Active comparator)
干预措施: Glivec film-coated tablet 100 mg, 4 Tablets (Drug)
结局指标
主要结局
Maximum concentration in plasma (Cmax) of Imatinib mesylate
时间窗: Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose
Area under the plasma concentration-time curve from zero time until the last measurable concentration (AUClast) of Imatinib mesylate
时间窗: Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose
次要结局
- Time to Cmax (Tmax) of Imatinib mesylate(Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose)
- Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of Imatinib mesylate(Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose)
- Terminal Elimination Half-life (t1/2) of Imatinib mesylate(Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose)