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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Mon, 27 Sep 2021 23:27:32 GMT) CTRI Number CTRI/2014/11/005156 [Registered on: 03/11/2014] - Trial Registered Prospectively Last Modified On 31/10/2014 Post Graduate Thesis No Type of Trial BA/BE Type of Study Study Design Randomized, Crossover Trial Public Title of Study Comparative study for Imatinib Mesylate 400mg tablets of Sponsor with Imatinib Mesylate 400mg tablets of (Gleevec®)Novartis Pharmaceuticals Corporation, New Jersey in patients with Chronic Myeloid Leukemia and/or Gastrointestinal Stromal Tumor under fed steady-state condition Scientific Title of A randomized, open label, two treatment, two period, two sequence, multiple dose, steady state Study 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 Secondary IDs if Any Secondary ID Identifier AZ/P/08/14/2,Version 01, 12 September 2014 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Dr S Gunasakaran MD Trial Coordinator (multi-center study) Designation Medical Advisor Affiliation Azidus Laboratories Ltd Address Azidus Laboratories Ltd, 23, School Road, Rathnamangalam, Vandalur, Chennai – 600048, India 23, School Road, Rathnamangalam, Vandalur, Chennai – 600048, India Kancheepuram TAMIL NADU 600048 India Phone 91-44-27405244 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr S Gunasakaran MD Query) Designation Medical Advisor Affiliation Azidus Laboratories Ltd Address Azidus Laboratories Ltd, 23, School Road, Rathnamangalam, Vandalur, Chennai – 600048, India 23, School Road, Rathnamangalam, Vandalur, Chennai – 600048, India Kancheepuram TAMIL NADU 600048 India Phone 91-44-27405244 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr S Gunasakaran MD Designation Medical Advisor Affiliation Azidus Laboratories Ltd Address Azidus Laboratories Ltd, 23, School Road, Rathnamangalam, page 1 / 6 PDF of Trial CTRI Website URL - http://ctri.nic.in Vandalur, Chennai – 600048, India 23, School Road, Rathnamangalam, Vandalur, Chennai – 600048, India Kancheepuram TAMIL NADU 600048 India Phone 91-44-27405244 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Natco Pharma Limited Primary Sponsor Primary Sponsor Details Name Natco Pharma Limited Address Natco House, Road, No-2, Banjara hills, Hyderabad-500033 91 40 2354 7532 Type of Sponsor Pharmaceutical industry-Indian Details of Secondary Name Address Sponsor AZIDUS Laboratories Ltd AZIDUS Laboratories Ltd., No.23rd School Road, Rathinamangalam, Behind Tagore Engg. College (Via) Vandalur, Kelambakkam Road, Chennai - 600 048. Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Arun Seshachalam Dr. GVN Cancer Department of Medical 9786220191 Institute Oncology #46, Singarathope, Trichy - [email protected] 620008 Tiruchirappalli TAMIL NADU Dr K Velavan Erode Cancer Centre Department of 9842334222 Radiation Oncology Velavan Nagar, [email protected] Perundurai Road, (Chinthamani Petrol Bunk) Erode - 638 012 Tamil Nadu, India Erode TAMIL NADU Dr T Kasi Viswanthan Meenakshi Mission Department of 9965606712 Hospital and Research Hematology Meenakshi Center Mission Hospital and [email protected] Research Center , Lake Area, Melur Road, Madurai 625107 Madurai TAMIL NADU Dr K C Lakshmaiah Srinivasam Cancer Department of Medical 9448055949 Care Hospital PVT Ltd Oncology No 236/1, Vijayashree Layout, [email protected] Arekere, Bennergahatta Main Road, Bangalore - 560076 Bangalore page 2 / 6 PDF of Trial CTRI Website URL - http://ctri.nic.in KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethics Approved 17/10/2014 No Committee - Meenakshi Mission Hospital and Research Center Institutional Ethics Submittted/Under No Date Specified No Committee Dr. GVN Review Cancer Institute Institutional Ethics Submittted/Under No Date Specified No Committee Erode Review Cancer Centre Institutional Ethics Approved 14/10/2014 No Committee Srinivasam Cancer Care Hospital PVT Ltd Regulatory Clearance Status Date Status from DCGI Approved/Obtained 13/10/2014 Health Condition / Health Type Condition Problems Studied Patients Gastrointestinal stromal tumors and/or chronic myeloid leukemia (CML) Intervention / Type Name Details Comparator Agent Comparator Agent GLEEVEC® (Imatinib mesylate) GLEEVEC® Imatinib mesylate 400 mg Tablets of Novartis 400mg tablet once daily for 10 Pharmaceuticals Corporation., days.Imatinib mesylate 400mg USA tablet once daily for 10 days.Overall treatment period in the study is of 20 days i.e. 10 days of period I and 10 days of period II. Patient will be administered Comparator Agent for 10 days in either of the study period. Study is having a randomized cross over design where the treatment will be allocated as per the randomization schedule. Intervention Imatinib mesylate 400 mg Imatinib mesylate 400mg tablet Tablets of Natco Pharma once daily for 10 days. Gleevec Limited (Imatinib mesylate 400mg) tablet once daily for 10 days.Overall treatment period in the study is of 20 days i.e. 10 days of period I and 10 days of period II. Patient will be administered Intervention Agent for 10 days in either of the study period. Study is having a randomized cross over design where the treatment will be allocated as per the randomization schedule. Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 60.00 Year(s) page 3 / 6 PDF of Trial CTRI Website URL - http://ctri.nic.in Gender Both Details Male and/or female patients with chronic myeloid leukemia or gastrointestinal stromal tumor with an age group of 18 to 60 years<br/> <br/> Patients on a stable regimen of 400 mg imatinib daily for at least 2 weeks before first dose with study drug<br/> <br/> 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).<br/> <br/> Female subjects must have a negative serum pregnancy test at screening and a negative urine pregnancy test upon check in to study facility.<br/> <br/> Patients with clinically insignificant liver function tests during check in of each period as decided by the investigator<br/> <br/> Able to provide informed consent after risks and benefits of the study have been explained to the subject and/or Legally Authorized personnel<br/> <br/> Normal and clinically insignificant biochemical, hematological (other than the indication studies) and urinary parameters<br/> <br/> Normal and clinically insignificant Chest X - ray PA view & ECG in 12 leads<br/> <br/> Negative for HIV 1 & 2, Hepatitis B, Hepatitis C, and Syphilis tests<br/> <br/> Negative urine test for drugs of abuse for morphine, barbiturates, benzodiazepines, amphetamine, THC & cocaine (to be performed on the day of check in)<br/> <br/> Negative alcohol breath analysis (to be performed on the day of check in, if required)<br/> <br/> 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<br/> <br/> Exclusion Criteria Exclusion Criteria Details 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 investigator’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. page 4 / 6 PDF of Trial CTRI Website URL - http://ctri.nic.in 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
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