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 Dr. Reddy’s Laboratories Limited, India to the reference listed drug Gleevec® (Imatinib Mesylate)Tablets 400 mg of Novartis Pharma Stein AG, Stein, Switzerland for Novartis PharmaceuticalsCorporation 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
- 32
- 试验地点
- 6
- 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 adult philadelphia chromosome positive chronic myeloid leukemia patients 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. To prevent healthy volunteers from adverse events and as per Guidance on the conduct of bioequivalence study with Imatinib Mesylate4, this study is proposed to be carried out on patients of Chronic Myeloid Leukaemia (CML) in chronic Phase who are stabilized with Imatinib Mesylate 400 mg for atleast 30 days and having documented evidence of Philadelphia chromosome positive.xml:namespace prefix = "o" ns = "urn:schemas-microsoft-com:office:office" /
The recommended dosing regime is Imatinib 400 mg 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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient and /or LAR or impartial witness able to give written informed consent for participation in the trial.
- •Male or female patients must be ≥ 18 years of age at the screening visit.
- •Patient must be stabilised with Imatinib Mesylate 400 mg for at least 30 days prior to dosing.
- •Patients of Chronic Myeloid Leukemia in chronic phase with documented evidence of Philadelphia chromosome positive (Ph+ CML).
- •Patient must have an ECOG performance status of 0-
- •Patient must have an adequate bone marrow, renal and hepatic function.
排除标准
- •Known hyper sensitivity to Imatinib or any of its excipients or related group of drugs.
- •Patients with known human immunodeficiency virus (HIV) infection.
- •A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies.
- •Patients of Ph+ CML in Accelerated Phase (AP) or Blast Crisis (BP).
- •Have previously undergone hematopoietic stem cell transplantation.
- •Use of any recreational drugs or history of drug addiction.
- •Any other condition or abnormal baseline findings that, in the investigator’s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
- •Patient with a history of difficulty in donating blood or difficulty in accessibility of veins.
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 adult philadelphia chromosome positive chronic myeloid leukemia patients stabilized with Imatinib mesylate 400 mg
时间窗: PK sample 0.500, 1.000,1.500
次要结局
- To monitor the safety of the patients exposed to the Investigational Medicinal Product.(End of study)