CTRI/2014/11/005156尚未招募未知
A randomized, open label, two treatment, two period, two sequence, multiple dose, steady state crossover, bioequivalence study of Imatinib mesylate 400 mg Tablets of Natco Pharma Limited, India and GLEEVEC® (Imatinib mesylate) 400 mg Tablets of Novartis Pharmaceuticals Corporation., USA in 40 patients with gastrointestinal stromal tumors and/or patients in their first three months of treatment for chronic myeloid leukemia (CML) under fed (light breakfast) conditions
atco Pharma Limited0 个研究点目标入组 40 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
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
- •Male and/or female patients with chronic myeloid leukemia or gastrointestinal stromal tumor with an age group of 18 to 60 years
- •Patients on a stable regimen of 400 mg imatinib daily for at least 2 weeks before first dose with study drug
- •Female patients practicing an acceptable method of birth control as judged by the investigator(s), such as condom with spermicide, diaphragm with spermicide, intrauterine device (IUD), or abstinence throughout the duration of the study; or of postmenopausal (no menses) status of at least 1 year; or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
- •Female subjects must have a negative serum pregnancy test at screening and a negative urine pregnancy test upon check in to study facility.
- •Patients with clinically insignificant liver function tests during check in of each period as decided by the investigator
- •Able to provide informed consent after risks and benefits of the study have been explained to the subject and/or Legally Authorized personnel
- •Normal and clinically insignificant biochemical, hematological (other than the indication studies) and urinary parameters
- •Normal and clinically insignificant Chest X - ray PA view & ECG in 12 leads
- •Negative for HIV 1 & 2, Hepatitis B, Hepatitis C, and Syphilis tests
- •Negative urine test for drugs of abuse for morphine, barbiturates, benzodiazepines, amphetamine, THC & cocaine (to be performed on the day of check in)
- •Negative alcohol breath analysis (to be performed on the day of check in, if required)
- •Subjects who had not bled in the past 3 months from the date of start of study either for blood donation or for any other reason
排除标准
- •Patients receiving imatinib for an indication that has not been approved by the FDA or for an indication that in the opinion of the Investigator may, during the conduct of the trial, become a primary treatment concern, or may lead to escalating doses of the study drug.
- •Clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening which, in the opinion of the Investigator, would jeopardize the safety of the patient, or affect the validity of the study results.
- •History of any major surgical procedure in the past 3 months.
- •History of diabetes mellitus, tuberculosis and systemic hypertension.
- •History suggestive of cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric or hematological systems, judged to be clinically significant other than the indication for which the study is being studies.
- •History of dysphagia.
- •History of any medical disorder that is of significance in the investigatorâ??s opinion.
- •History of smoking 9 or more cigarettes or beedies per day and / or inability to withhold smoking or consumption of tobacco containing products during the study.
- •History of any drug abuse in the past 12 months.
- •History of hypersensitivity to study medications and related drugs or excipients in the formulation (if the excipients are known).
- •History of allergy to vegetables and / or food substances and / or any other manifestations suggestive of hypersensitivity reactions.
- •Any disease or condition (medical or surgical) that, in the opinion of the investigator, might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system function; or any condition that might interfere with the absorption, distribution, metabolism, or excretion of the study drug or that would place the subject at increased risk.
- •Less than 18 years of age.
- •Pregnant or lactating women.
- •History of hypersensitivity reactions to any components of Imatinib.
- •Treatment with any drugs known to be inhibitors or inducers of CYP3A4 within 30 days prior to study drug administration or during the study
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