CTRI/2016/08/007155已完成不适用
A Multi Center Open Label Balanced Randomized Two Treatment Two Sequence Two Period Crossover SteadyState Bioequivalence Study of Imatinib Mesylate Tablets 400 mg Test of Eugia Pharma Specialities Limited India A joint venture of Aurobindo Pharma Limited and Celon Laboratories Limited and Gleevec® Imatinib Mesylate 400 mg Tablets Reference of Novartis Pharmaceuticals Corporation USA in 36 adult patients with Chronic Myeloid Leukemia and or Gastro Intestinal Stromal Tumors already receiving Imatinib Mesylate Tablets 400 mg under fed conditions
Eugia Pharma Specialities Limited A JV of Aurobindo Pharma Limited and Celon Laboratories Limited5 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年5月17日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 5
- 主要终点
- AUC0-ï´ -: Area under the plasma concentration – time curve over the steady state dosing interval.
研究概览
简要总结
This is a multicentre study and the Primary objective will be to determine clinical Bioequivalence of Imatinib Mesylate 400mg ( Eugia Specialities-Test ) with Gleevec (R) -Reference of Novartis Pharamaceutcals Corporation , USA . The study will be done in 36 adult evaluable subjects with Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumor . The secondary object of this study is to asses safety and tolerability as asseses by the reported adverse events .
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female subject aged between 18 and 65 years of age (both inclusive) at the time of informed consent and should have BMI ≥ 18.5 to ≤ 30 kg/m
- •2.Subject with chronic phase Ph+ CML (Philadelphia chromosome positive Chronic Myeloid Leukemia) in their first three months of treatment and /or Gastro Intestinal Stromal Tumors (GIST) who are on stable dose regimen of Imatinib Mesylate 400 mg daily dose 3.Subject with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase OR Subject with GIST diagnosed histologically with expressing CD117+ or with documented mutation of the KIT or PDGFRA gene 4.Female subject of childbearing potential should be willing to use a reliable method of birth control 5.Female subject must have a negative pregnancy test at Screening.
- •6.Subject should be otherwise healthy as determined by general and systemic examination, medical history and have no significant abnormality in any of the laboratory parameters including ECG and Chest X-ray.
- •7.Subject with ECOG (Eastern Cooperative Oncology Group) performance status 0-2 8.Subject with no history of addiction to any recreational drug or drug dependence 9.Subject must be able to adhere to the study visit schedule and other protocol requirements and must have given informed consent prior to any screening procedures.
排除标准
- •1.Subject with history of accelerated or blast phase CML 2.Subject with history of ascites and rapid weight gain with or without superficial edema 3.Subject had uncontrolled diabetes mellitus at the discretion of Principal Investigator 4.Subject with history of hematopoietic stem cell transplantation.
- •5.Subject had prior radiotherapy to bone marrow 6.Subject undergone major surgery within 4 weeks of enrolment.
- •7.Subject use of other concurrent anticancer agents, including chemotherapy or biologic agents.
- •8.Subject had history of hypersensitivity or idiosyncratic reactions to any drug product or its excipients etc 9.History of difficulty with donating blood or difficulty in swallowing the drug or difficulty in accessibility of veins.
- •10.High caffeine (more than 5 cups of coffee or tea/day) or tobacco (more than 9 cigarettes/ beedies/ cigars per day) consumption.
- •11.Subject diagnosed to be HIV 1 and 2 or Hepatitis B (HBs Ag) or Hepatitis C (HCV) virus reactive/positive.
- •12.Female subject who is pregnant or currently breast-feeding.
- •13.Subject donated blood ≥ 350 mL within 90 days of screening.
- •14.Subject participation in another clinical trial within the preceding 90 days of study starts.
- •15.Use of concomitant medication with drugs known to be inhibitors and/or inducers of CYP3A4 family and acetaminophen (paracetamol) 16.Subject with history of arterial thrombosis or deep vein thrombosis within the past year 17.Subject had significant pre-existing co-morbidities a.Cardiovascular •Congestive heart failure •Uncontrolled hypertension b.Pulmonary •pleural effusion, pulmonary edema c.Neurologic and psychiatric •History of significant neurologic or psychiatric disorder that would preclude study compliance or ability to give informed consent d.Gastrointestinal •Severe Diarrhea and Vomiting •Inflammatory bowel diseases Liver or Kidney disease.
结局指标
主要结局
AUC0-ï´ -: Area under the plasma concentration – time curve over the steady state dosing interval.
时间窗: Day 1, 5, 6, 8, 12 and 13: Venous blood samples will be withdrawn 5 minutes prior to morning dosing to confirm steady state condition. ( 3 days/ 12 mL/ period) | Day 7 and 14: Venous blood samples will be withdrawn at 0.00 (pre-dose) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 18.00 and 24.00 hours of post dose in each period.
Cmax-ss: Maximum concentration over the steady state dosing interval.
时间窗: Day 1, 5, 6, 8, 12 and 13: Venous blood samples will be withdrawn 5 minutes prior to morning dosing to confirm steady state condition. ( 3 days/ 12 mL/ period) | Day 7 and 14: Venous blood samples will be withdrawn at 0.00 (pre-dose) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 18.00 and 24.00 hours of post dose in each period.
次要结局
- Css-avg: Average concentration over the steady state dosing interval.(Day 1, 5, 6, 8, 12 and 13: Venous blood samples will be withdrawn 5 minutes prior to morning dosing to confirm steady state condition. ( 3 days/ 12 mL/ period))
研究者
研究点 (5)
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