Health Condition 1: null- GASTROINTESTINAL STROMAL TUMORS OR CHRONIC MYELOID LEUKEMIA UNDER FED CONDITIONS.
Conditions
Interventions
Intervention1: Imatinib Mesylate Tablets 400 mg
OD Oral for 8 days: Manufactured by: Cadila Healthcare Ltd., India.
Control Intervention1: GLEEVECâ?? (Imatinib Mesylate) Tablets 400 mg
OD
Oral for 8
Sponsors
Cadila healthcare Ltd
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 3) Life expectancy of at least 3 months. 4) Having ECOG status 5) Patients willing to not change their concurrent medications during the study. 6) All patients should have a Body Mass Index (BMI) less than or equal to 30 but greater than or equal to 18. 7) Able to comply with Protocol requirements and assessments 8) Able to give written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: • Patients presenting with any of the following will be excluded from the study: • History of allergic responses to Imatinib Mesylate, or other related drugs and any of its formulation ingredients. • 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). • Major surgery to the gastrointestinal tract, the liver or kidney within 4 weeks of study entry which may impact on the pharmacokinetics of Imatinib. • History of difficulty in swallowing, or any gastrointestinal disease which could affect drug absorption. • Patients with cardiac disease or risk factors for cardiac failure. • Patients with prior History of erythema multiforme or Stevens-Johnson syndrome • Patients with History of Hypothyroidism or currently suffering from Hypothyroidism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax,ss, AUCtau, Tmax,ss, Cmin,ss,Cav,ss, degree of Fluctuation and swing will be calculated for Imatinib Timepoint: 0.25 hrs, 0.5 hrs, 1.0 hrs, 1.5 hrs, 2.0 hrs, 2.5 hrs, 3.0 hrs, 3.5 hrs, 4.0 hrs, 4.5 hrs, 5.0 hrs, 5.5 hrs, 6.0 hrs, 8.0 hrs, 12.0 hrs, 16.0 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and Adverse events.Timepoint: NA | — |
Countries
India
Contacts
Public ContactDr Chirag Shah
Cliantha Research Limited
Outcome results
None listed