CTRI/2016/10/007398已完成不适用
An Open-Label, Randomized, Two-Period, Two-Treatment, Two-Sequence, Multiple Dose, Steady-State, Crossover, Multicentre, Bioequivalence Study Of Imatinib Mesylate Tablets 400 mg Of Cadila Healthcare Ltd., India And ‘Gleevec’ (Imatinib Mesylate) Tablets 400 mg Of Novartis Pharmaceuticals Corporation, USA In Patients With Gastrointestinal Stromal Tumors Or Chronic Myeloid Leukemia Under Fed Conditions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 6
- 主要终点
- of Fluctuation and swing will be calculated for Imatinib
研究概览
简要总结
Thisis an open-label, randomized, two-period, two-treatment, two-sequence,multiple-dose, steady-state, cross-over, multicentre, pharmacokinetic bioequivalencestudy in patients with Gastrointestinal Stromal Tumors or Chronic MyeloidLeukemia under fed conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 79.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients must be receiving stable doses of Imatinib (i.e. 400 mg once a day) for the treatment of Gastrointestinal Stromal Tumors or Chronic Myeloid Leukemia.
- •Males or non pregnant or non lactating females of age ≥ 18 years and ≤ 79 years.
- •Life expectancy of at least 3 months.
- •Having ECOG status ≤ 2 5)Patients willing to not change their concurrent medications during the study.
- •All patients should have a Body Mass Index (BMI) less than or equal to 30 but greater than or equal to
- •Able to comply with Protocol requirements and assessments 8)Able to give written informed consent to participate in the study.
排除标准
- •â€¢Patients presenting with any of the following will be excluded from the study: •History of allergic responses to Imatinib Mesylate, or other related drugs and any of its formulation ingredients.
- •â€¢Patients receiving concomitant therapy of warfarin (coumarin anticoagulants) or history of usage of coumarin anticoagulants in the previous three months prior to study start (dosing).
- •â€¢Major surgery to the gastrointestinal tract, the liver or kidney within 4 weeks of study entry which may impact on the pharmacokinetics of Imatinib.
- •â€¢History of difficulty in swallowing, or any gastrointestinal disease which could affect drug absorption.
- •â€¢Patients with cardiac disease or risk factors for cardiac failure.
- •â€¢Patients with prior History of erythema multiforme or Stevens-Johnson syndrome •Patients with History of Hypothyroidism or currently suffering from Hypothyroidism.
结局指标
主要结局
of Fluctuation and swing will be calculated for Imatinib
时间窗: 0.25 hrs, 0.5 hrs, 1.0 hrs, 1.5 hrs, 2.0 hrs, 2.5 hrs, 3.0 hrs, 3.5 hrs, 4.0 hrs, 4.5 hrs, 5.0 hrs, 5.5 hrs, 6.0 hrs, 8.0 hrs, 12.0 hrs, 16.0 hrs
Cmax,ss, AUCtau, Tmax,ss, Cmin,ss,Cav,ss, degree
时间窗: 0.25 hrs, 0.5 hrs, 1.0 hrs, 1.5 hrs, 2.0 hrs, 2.5 hrs, 3.0 hrs, 3.5 hrs, 4.0 hrs, 4.5 hrs, 5.0 hrs, 5.5 hrs, 6.0 hrs, 8.0 hrs, 12.0 hrs, 16.0 hrs
次要结局
- Safety and Adverse events.(NA)
研究者
研究点 (6)
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