A Randomized, Open Label, Two-Treatment, Multiple Dose, Steady State, Two-period, Cross-over, Multi-Centre Comparative Bioequivalence Study of Imatinib Mesylate Tablet 400 mg of Amneal Pharmaceuticals, USA with GLEEVECÂ® (Imatinib Mesylate) Tablet 400 mg Distributed by Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 in Adult Patients Suffering from Chronic Myeloid Leukemia & Gastrointestinal Stromal Tumor under Fed Conditions.

Amneal Pharmaceuticals LLC0 个研究点目标入组 48 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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•2. Diagnosed case of Philadelphia chromosome positive (Ph+) CML or GIST and presently being treated with imatinib 400 mg tablets.
•3. Willing to give written informed consent for participation in the trial as well as willing and able to comply with study visit schedule and other protocol requirements.
•4. Female patients of child bearing potential (except for those who have completed one year since menopause or have been hysterectomized) must have negative serum pregnancy test at the screening, negative urine pregnancy test on check in to housing and must agree to use effective contraception (barrier or hormonal) for the study period.

•The Patients with any of the following criteria should be excluded.
•1. History of hypersensitivity to imatinib mesylate or to any of the excipients as judged by investigator.
•2. Patient of CML receiving treatment in Myeloid Blast Crisis or Accelerated Phase
•3. Abnormal laboratory results as below,
•Absolute neutrophils count less than 1000/ mm3
•Platelet Count less than 50,000/mm3
•SGOT and/or SGPT greater than 5 times upper limit of normal (ULN)
•Serum total Bilirubin greater than 3 times ULN
•Serum TSH greater than 10 microIU/mL
•Serum Uric Acid greater than 12 mg/dL
•Reactive for HIV antibody, HBsAg or HCV antibody
•4. History of a heart failure, renal insufficiency, hypereosinophilic syndrome (HES), myelodysplastic syndrome (MDS)/ myeloproliferative disease (MPD) or acute systemic mastocytosis (ASM).
•5. History of therapy with any of the following as per timelines before randomization,
•Inducers of CYP3A4 activity within 14 days
•Inhibitors of CYP3A4 activity within 14 days.
•Investigational product/ device within last one month
•6. Alcohol or any drug dependence within past one year.
•7. Blood donation/ loss exceeding 200 ml within last 60 days.

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