CTRI/2015/02/005508已完成未知
A multicenter, open label, randomized, balanced, steady state, two treatment, two period, two sequence, two-way crossover, multiple dose, bioequivalence study of Imatinib Mesylate Tablets 400mg of Dr. Reddyâ??s Laboratories Limited, India with Gleevec® (Imatinib Mesylate) Tablets 400mg of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey in adult human patients with Chronic Myeloid Leukemia and/or Gastrointestinal Stromal Tumor stabilized on Imatinib Mesylate 400 mg under fed condition - NA
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1.Men and Women, of age in between 18 years to 65 years (both inclusive).
- •2.Ability to provide written informed consent prior to participation in the study
- •3.Women of childbearing potential must have a negative serum or urine pregnancy test, must be using an adequate method of contraception.
- •4.Patients with
- •Chronic Phase Philadelphia chromosome positive Chronic Myeloid Leukemia who are on stable dose regimen of 400mg daily dose of Imatinib
- •Gastrointestinal Stromal Tumor (GIST) who are on a stable dose regimen of 400 mg daily
- •dose of Imatinib
- •5.Documented evidence of chronic phase CML & positive for Philadelphia chromosome
- •6.Adequate organ function, defined as the following:
- •ï??Total bilirubin < 1.5 x upper limit of normal (ULN)
- •ï??SGOT and SGPT < 2.5 x ULN
- •ï??Serum Creatinine < 1.5 x ULN
- •ï??Absolute neutrophil count (ANC) >= 1.5 x 109/L
- •ï??Platelets >= 100 x 109/L
- •7.Patients for whom a titration away from 400 mg dose is unlikely.
- •8.No history of addiction to any recreational drug or drug dependence
- •9.No history of participation in any clinical study within the past 90 days
排除标准
- •1.Patients in accelerated phase or blastic phase are excluded
- •2.History of patients who require >400mg daily dose of Imatinib
- •3.Patient received any treatment for CML prior to study entry for longer than 2 weeks with the exception of hydroxyurea and/or anagrelide
- •4.History of patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention
- •5.Patients who are:
- •ï??Pregnant
- •ï??Breast feeding
- •ï??Of childbearing potential without a negative pregnancy test prior to baseline
- •ï??Male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial
- •6.Patient having history of major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery
- •7.Patients with an ECOG (Eastern Cooperative Oncology group) Performance Status Score >= 3
- •8.Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent
- •9.Patients with identified sibling donors where allogeneic bone marrow transplant is elected as first line treatment
- •10.Taking CYP3A4 inhibitors and/or inducers which is as per the detailed drug list in Annexure IV.
- •11.Having History of Hematopoietic stem cell transplantation.
- •12.History of hypersensitivity to Imatinib or any of its excipients or related group of drugs.
- •13.Patients who are eligible and willing to undergo transplantation during the screening period.
- •14.History of patients taking certain medications that are accepted to have a risk of causing Torsades de Pointes.
- •15.History of patients taking medications that irreversibly inhibit platelet function or anticoagulants.
- •16.History of Uncontrolled diseases, such as thyroidal dysfunction, diabetes mellitus, angina pectoralis, serious heart failure, neuropsychiatric infection or disease.
- •17.History of alcohol and/or drug addiction.
- •18.Patients with known positivity for human immunodeficiency virus (HIV), HBsAg and HCV
- •19.History of ascites and rapid weight gain with or without superficial edema
- •20.Grade 3 or 4 neutropenia and thrombocytopenia as per the screening laboratory reports.
- •21.History of hematopoietic stem cell transplantation.
- •22.History of prior radiotherapy to bone marrow
- •23.Use of other concurrent anticancer agents other than Imatinib, including chemotherapy or biologic agents.
- •24.Positive results for drugs of abuse (benzodiazepines, opioids, amphetamines, cannabinoids cocaine and barbiturates) in urine
- •25.Positive results for alcohol as detected by Alcohol Breath Analyzer.
- •26.History of difficulty with donating blood or difficulty in accessibility of veins.
- •27.An unusual or abnormal diet, for whatever reason e.g. religious fasting.
- •28.High caffeine (more than 5 cups of coffee or tea/day) or tobacco (more than 9 cigarettes/ beedies/ cigars per day) consumption.
- •29.History of patient for whom oral administration of drug is not possible.
- •30.History of donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study.
- •31.Any other condition or abnormal baseline findings that, in the investigatorâ??s judgment, migh
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