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 GleevecÂ® (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

Ranbaxy Laboratories Limited0 个研究点目标入组 42 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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 0-2.
•6.Patient must have an adequate bone marrow, renal and hepatic function

•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 investigatorâ??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.
•9.Patient with a history of difficulty in donating blood or difficulty in accessibility of veins.

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