Health Condition 1: null- CHRONIC MYELOID LEUKEMIA (CML)
Conditions
Interventions
Intervention1: Imatinib Mesylate Tablets): The subjects will randomly receive 400 mg once daily of the Imatinib Mesylate 400 mg tablet [i.e. either Reference formulation or Test formulation] with 240
Sponsors
Sun Pharmaceutical Industries Ltd
Eligibility
Inclusion criteria
Inclusion criteria: i. Availability of subject for the entire study period and willingness to adhere to protocol requirements. ii. Patients between 18 to 60 years of age. iii. Patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase iv. Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase after failure of interferon-alpha therapy. v. Subjects with Performance vi. Subjects who have no evidence of underlying disease which in the judgment of the investigator would not make the subject inappropriate for getting enrolled in the study (except CML) during screening, medical history and whose physical examination is performed within 21 days prior to commencement of the study. vii. Subjects whose screening laboratory values are within normal limits or considered by the Investigator/sub-Investigator to be of no clinical significance. viii. Informed consent form given in written form according to section 9.3 of the protocol. ix. Female Subjects • of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence. OR • Postmenopausal for at least 1 year. OR • surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)
Exclusion criteria
Exclusion criteria: 1. History or presence of significant: • Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Imatinib Mesylate and/or any related compounds etc. • Cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease which has an impact on subject safety and does not permit dosing of imatinib. • Use of following drugs as concurrent therapy: Erythromycin, warfarin, CYP inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) or CYP inducers (e.g. dexamethasone, phenytoin, carbamazepine, oxcarbazepine, rifampicin, rifabutin, Rifampin, phenobarbital, fosphenytoin, primidone or Hypericum perforatum, also known as St. Johns Wort, Griseofulvin). • Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year. • Smoking (>= 10 cigarettes/day) or consumption of tobacco products (>= 4 chews/day). • History of difficulty in swallowing or coming for follow up. • Subjects who have been on an abnormal diet (for whatever the reason) during the four weeks preceding the study • Female subject who is pregnant, lactating or likely to become pregnant or have a positive pregnancy test at screening and prior to study. • Positive result to HIV, HCV, RPR and HBsAg. • Abnormal 12 lead ECG, X-ray. 2 Donation of 350 mL or more of blood in the previous 90 days before day 1 of this study 3 Participation in another clinical trial within the preceding 90 days of study starts. 4 Subjects who have: • Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg • Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4mm Hg) at check-in may be acceptable at the discretion of the investigator. • Pulse rate below 60/min. or above 100/min.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To monitor the safety of the subjects participating in the study and to assess the steady-state bioequivalence of Imatinib Mesylate 400 mg tablets of Sun Pharmaceutical Industries Ltd, India and Gleevec (Imatinib Mesylate) 400 mg Tablets of Novartis Pharmaceuticals Corporation under fed condition.Timepoint: From Day-0 to Day-31. | — |
Secondary
| Measure | Time frame |
|---|---|
| N/ATimepoint: N/A | — |
Countries
India
Contacts
Public ContactDr Aman Khanna MD
Sun Pharmaceutical Industries Ltd.
Outcome results
None listed