Health Condition 1: null- Patients with Gastrointestinal Stromal Tumors or Chronic Myeloid Leukemia
Conditions
Interventions
Intervention1: Imatinib Mesylate Tablets 400 mg of Cadila Healthcare Ltd
: Imatinib Mesylate Tablets 400 mg
Single Dose, Orally
Control Intervention1: â??GLEEVECâ?? (Imatinib Mesylate) Tablets 400 mg
Sponsors
Cadila Healthcare Ltd
Cliantha Research Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients must be receiving stable doses of Imatinib (i.e. 400 mg once a day) for the treatment of Gastrointestinal Stromal Tumors or Chronic Myeloid Leukemia. 2) Males or non pregnant or non lactating females of age >= 18 years and a) Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days prior to initiation of the study & at the time of check-in of first period. b) Acceptable forms of contraception include the following: i. Intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or ii. Barrier methods containing or used in conjunction with a spermicidal agent, or iii. Surgical sterilization, or iv. Practicing sexual abstinence throughout the course of the study c) Females will not be considered of childbearing potential if one of the following is reported and documented on the medical history: i. Postmenopausal with spontaneous amenorrhea for at least one year, or ii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iii. Total hysterectomy and an absence of bleeding for at least 3 months 3) Life expectancy of at least 3 months. 4) Patients willing to not change their concurrent medications during the study. 5) All patients should have a Body Mass Index (BMI) less than or equal to 30 but greater than or equal to 18. BMI values should be rounded to the nearest integer. (e.g. 30.4 rounds down to 30, while 17.5 rounds up to 18) 6) Able to comply with Protocol requirements and assessments 7) Able to give written informed consent to participate in the study 8) All patients should be judged eligible by the principal investigator or co-investigator or physician during a pre-study safety assessment performed within 28 days of the first dose of study medication which will include a) A complete medical history b) A normal or clinically non-significant physical examination. c) Within normal limits or clinically non-significant laboratory evaluation results (unless otherwise noted in the exclusion criteria)
Exclusion criteria
Exclusion criteria: Patients must not be enrolled in the study if they meet any one of the following criteria: 1) History of allergic responses to Imatinib Mesylate, or other related drugs and any of its formulation ingredients. 2) Patients receiving concomitant therapy of warfarin (coumarin anticoagulants) or history of usage of coumarin anticoagulants in the previous three months prior to study start (dosing). 3) Consumption of grapefruit, grapefruit-like or grapefruit containing products within 7 days of drug administration. 4) Ingestion of any alcoholic, caffeine or xanthine containing food or beverage within the 48 hours prior to the initial dose of study medication. 5) Use of enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication (listed in Appendix-II). They can be allowed depending on Principal Investigatorâ??s discretion in consultation with Medical monitor, if they are kept constant in the last 30 days and are expected to remain constant during the study period. 6) Use of drugs metabolized by CYP3A4 and having a narrow therapeutic window like alfentanil, cyclosporine, diergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus or tacrolimus. 7) History of moderate (30-50 ml/min creatinine clearance) or severe ( 8) Impaired hepatic function (bilirubin >=2 times the upper limit of normal, transaminases or alkaline phosphatase >= 2.5 times the upper limit of normal). 9) Major surgery to the gastrointestinal tract, the liver or kidney within 4 weeks of study entry which may impact on the pharmacokinetics of Imatinib. 10) Participation in any investigational drug study within 30 days prior to period 1 dosing. 11) History of difficulty in swallowing, or any gastrointestinal disease which could affect drug absorption. 12) Patients with cardiac disease or risk factors for cardiac failure. 13) Patients with prior History of erythema multiforme or Stevens-Johnson syndrome 14) Patients with History of Hypothyroidism or currently suffering from Hypothyroidism. 15) Patients with History of Immunosuppression or in current Immunosuppression 16) Patients with History of Tumor lysis syndrome 17) Patients currently suffering from generalized edema and fluid retention (such as pleural effusion, pericardial effusion or ascites) 18) Patients with prolonged QT or clinically significant ECG changes 19) Donation or loss of blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in the previous 60 days. 20) Any significant disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system. 21) History of drug dependence, history of alcoholism in the past 2 years prior to screening. 22) Smokers, who smoke more than or equal to 10 cigarettes per day or more than or equal to 20 biddies per day or those who cannot refrain from smoking during study period. 23) History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venipuncture. 24) History of allergic response to heparin. 25) A positive hepatitis screen (includes subtypes B & C) 26) A positive test result for HIV antibody and / or syphilis (RPR/VDRL) 27
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters Cmax, AUC24, AUCt and TmaxTimepoint: Pharmacokinetic parameters Cmax, AUC24, AUCt and Tmax | — |
Secondary
| Measure | Time frame |
|---|---|
| bioequivalence study of Imatinib Mesylate Tablets 400 mg of Cadila Healthcare Ltd., India and â??GLEEVECâ?? (Imatinib Mesylate) Tablets 400 mg of Novartis Pharmaceuticals Corporation, USA in patients with Gastrointestinal Stromal Tumors or Chronic Myeloid Leukemia under fed conditions and to monitor safety of the patientsTimepoint: Pharmacokinetic parameters Cmax, AUC24, AUCt and Tmax | — |
Countries
India
Contacts
Public ContactDr Chirag Shah
Cliantha Research Limited
Outcome results
None listed