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 â??Gleevecâ?? (Imatinib Mesylate) Tablets 400 mg Of Novartis Pharmaceuticals Corporation, USA In Patients With Gastrointestinal Stromal Tumors Or Chronic Myeloid Leukemia Under Fed Conditions.

Cadila healthcare Ltd0 个研究点目标入组 0 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)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.
•2)Males or non pregnant or non lactating females of age >= 18 years and <= 79 years.
•3)Life expectancy of at least 3 months.
•4)Having ECOG status <= 2
•5)Patients willing to not change their concurrent medications during the study.
•6)All patients should have a Body Mass Index (BMI) less than or equal to 30 but greater than or equal to 18.
•7)Able to comply with Protocol requirements and assessments
•8)Able to give written informed consent to participate in the study

•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.
•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).
•Major surgery to the gastrointestinal tract, the liver or kidney within 4 weeks of study entry which may impact on the pharmacokinetics of Imatinib.
•History of difficulty in swallowing, or any gastrointestinal disease which could affect drug absorption.
•Patients with cardiac disease or risk factors for cardiac failure.
•Patients with prior History of erythema multiforme or Stevens-Johnson syndrome
•Patients with History of Hypothyroidism or currently suffering from Hypothyroidism.

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