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 Qilu Pharmaceutical (Hainan) Co.,Ltd. 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 or Gastrointestinal Stromal Tumor under Fed Conditions

Qilu Pharmaceutical Co Ltd0 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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•1.Age 18 to 55 years (both inclusive) and either sex.
•2.Diagnosed case of Philadelphia chromosome positive (Ph+) CML patients in chronic phase or GIST and presently being treated with imatinib 400 mg tablets
•3.Eastern Cooperative Oncology Group (ECOG) performance status of 0â??2.
•4.Willing to give written informed consent for participation in the study as well as willing and able to comply with study visit schedule and other protocol requirements.
•5.Patientâ??s screening laboratory assessments are clinically non-significant as per the discretion of the Investigator.
•6.Female patients of child bearing potential (except for those who have completed one year since menopause or have gone through hysterectomy or bilateral tubal ligation) must have negative serum pregnancy test at the screening, negative urine pregnancy test on check in to housing, must be non-lactating at screening and must agree to use effective contraception (barrier or hormonal) for the study period.

•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
•The Patients with any of the following criteria should be excluded:
•3.Abnormal laboratory results as below:
•Absolute neutrophils count < 1 x 109/L or < 1000/ mm3
•Platelet Count < 50 x 109/L or 50,000/mm3
•SGOT &/or SGPT > 5 times upper limit of normal (ULN)
•Serum total Bilirubin > 3 times ULN
•Serum TSH > 10 Î¼IU/mL
•Serum Uric Acid > 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.Alcohol or any drug dependence within past one year.
•6.Blood donation/ loss exceeding 200 mL within last 60 days.
•7.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

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