A multicentre, randomized, open label, steady state, two treatment, two period, two-way crossover, bioequivalence study under fed conditions comparing Imatinib Mesylate Tablets 400 mg of Intas Pharmaceuticals Limited, India to the reference listed drug Gleevec® (Imatinib Mesylate) Tablets 400 mg of Novartis Pharma Stein AG, Stein, Switzerland for Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 in patients of Philadelphia chromosome positive Chronic Myeloid Leukaemia (CML), stabilized on Imatinib Mesylate 400 mg
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 5
- 主要终点
- To characterize the pharmacokinetic profile of the sponsor’s test formulation (Imatinib Mesylate Tablets 400 mg) relative to that of reference formulation (Gleevec® (Imatinib Mesylate) Tablets 400mg) in chronic myeloid leukemia patients and to assess the bioequivalence.
研究概览
简要总结
Imatinib mesylate (Imatinib) is a selective inhibitor of the protein tyrosine kinase associated with bcr-abl and specifically inhibits proliferation of Ph expressing cells. To prevent healthy volunteers from adverse events and as per Guidance on the conduct of bioequivalence study with Imatinib Mesylate3, this study is proposed to be carried out on patients of Chronic Myeloid Leukaemia (CML).
In this study, Imatinib Mesylate Tablets 400 mg or Gleevec® (Imatinib Mesylate) Tablets 400 mg will be administered to patients at an interval of 24 hr for 14 days Following oral administration, the elimination half-life of Imatinib and its major active metabolite, the N-demethyl derivative, are approximately 18 and 40 hours, respectively.
Therefore, this steady state multiple dose study will be performed in patients of Chronic Myeloid Leukaemia (CML).
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients able to give informed consent for participation in the trial.
- •2.Male or female patients must be 18 to 65 years of age (both inclusive) at the screening visit.
- •3.Patients of Philadelphia chromosome positive Chronic Myeloid Leukemia 4.Patient should be able to comply with study procedures in the opinion of the investigator.
- •5.Male or Female patient must agree to use an effective measures of Contraception during the study.
排除标准
- •1.Known hyper sensitivity to Imatinib or any of its excipients or related group of drugs.
- •2.Patients with known human immunodeficiency virus (HIV) infection.
- •3.A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies.
- •4.Use of any recreational drugs or history of drug addiction.
- •5.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.
- •6.Any other condition or abnormal baseline findings that, in the investigator’s judgement, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
结局指标
主要结局
To characterize the pharmacokinetic profile of the sponsor’s test formulation (Imatinib Mesylate Tablets 400 mg) relative to that of reference formulation (Gleevec® (Imatinib Mesylate) Tablets 400mg) in chronic myeloid leukemia patients and to assess the bioequivalence.
时间窗: 14 Days
次要结局
- To monitor the safety of the patients exposed to the Investigational Medicinal Product.(Before and at the end of the study)