A multicentre, randomized, open label, single dose, two treatment, two period, two sequence, crossover, bioequivalence study under fed conditions comparing of Imatinib Mesylate 400 mg tablets (Ranbaxy Laboratories Limited, India) to the reference listed drug Gleevec® (Imatinib Mesylate) Tablets 400 mg (Novartis Pharmaceuticals Corporation, East Hanover, New Jersey-07936) in patients of Philadelphia chromosome positive Chronic Myeloid Leukaemia stabilized on Imatinib Mesylate tablets 400mg
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 9
- 主要终点
- To characterize the pharmacokinetic profile and assess bioequivalence of the sponsor’s test formulation (Imatinib Mesylate 400 mg tablets) relative to that of reference formulation (Gleevec® 400 mg tablets) in adult patients of philadelphia chromosome positive chronic myeloid leukemia stabilized with Imatinib mesylate 400 mg
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. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
As per available guidance on Imatinib Mesylate, US FDA recommends to conduct a single dose study in patients already receiving a stable dose of Imatinib tablets, 400 mg and recruitment efforts should be targeted at patients for whom a titration away from the 400 mg dose is unlikely, such as patients with gastrointestinal stromal tumors and patients in their first three months of treatment for chronic myeloid leukemia (CML).
The recommended dosing regime is Imatinib Mesylate 400 mg tablet daily for adult patients of Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Treatment may be continued as long as there is no evidence of progressive disease or unacceptable toxicity
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient able to give written informed consent for participation in the trial 2.Male or female patients must be ≥ 18 years of age at the screening visit.
- •3.Patient must be on stable dose of Imatinib Mesylate 400 mg tablets.
- •4.Patients of Chronic Myeloid Leukemia in chronic phase with documented evidence of Philadelphia chromosome positive (Ph+ CML).
- •5.Patient must have an ECOG performance status of 0-
- •6.Patient must have an adequate bone marrow, renal and hepatic function.
排除标准
- •1.Known Hypersensitivity to the active substance or to any of the excipients of Imatinib tablets.
- •2.Patients with known human immunodeficiency virus (HIV) infection.
- •3.A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies.
- •4.Patients of Ph+ CML in Accelerated Phase (AP) or Blast Crisis (BP).
- •5.If the patient have previously undergone hematopoietic stem cell transplantation.
- •6.Significant bleeding disorder unrelated to CML.
- •7.Use of any recreational drugs or history of drug addiction.
- •8.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 and assess bioequivalence of the sponsor’s test formulation (Imatinib Mesylate 400 mg tablets) relative to that of reference formulation (Gleevec® 400 mg tablets) in adult patients of philadelphia chromosome positive chronic myeloid leukemia stabilized with Imatinib mesylate 400 mg
时间窗: PK sample- | 0.500,3.000,5.000,20.000
次要结局
- To monitor the safety of the patients exposed to the Investigational Medicinal Products(End of the study)