Effect of Food on Bioavailability of a Modified Release Formulation of Imatinib
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This is a single center, four-treatment, four period, crossover study to evaluate the effect of food on the relative bioavailability of a single dose of imatinib (STI571) given as a 800 mg modified release tablet, MR2 compared to twice-daily doses of 400 mg film-coated imatinib tablets. There will be a 10 day wash out phase between treatments and a 1 week safety period at the end of the study. Each participant will receive all four treatments
A Phase I, Open-label, Randomized, Crossover Study to Investigate the Effect of Food on the Bioavailability of a Single 800 mg Imatinib Dose in a Modified Release Formulation (MR2) and Compare the Bioavailability Between MR2 and Imatinib 400 mg Twice Daily Immediate Release Tablet (IR) in Healthy Subjects
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Assess the effect of food on bioavailability and pharmacokinetics of modified and immediate release formulations of imatinib
Secondary Outcome Measures :
To compare safety and tolerability of 800 mg modified release formulation with or without food.
To compare the relative bioavailability of a single dose 800 mg modified release formulation (with a low fat breakfast) with the marketed 400 mg immediate release tablet administered (with a low fat breakfast) twice daily
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Ages Eligible for Study:
40 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy male or female subjects (postmenopausal women)
Able to communicate well with the investigator and comply with the requirements of the study.
Subjects using any prescription drug or over-the-counter (OTC) medication (including herbal and alternative medication) within 2 weeks prior to dosing.
Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
A past medical history or presence of clinically significant ECG abnormalities including:
History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
History of medications pre-disposing the subjects for GI bleedings/cerebral hemorrhage.
Women taking any biphosphonates (Fosomax like drugs)
History of being immunocompromised, including a positive HIV test result.
A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
Females nursing infants. Other protocol-defined inclusion/exclusion criteria may apply.