Effect of Food on Bioavailability of Modified Release Formulations of Imatinib

A Phase I, Two Arm, Open-label, Randomized, Study to Investigate the Effect of Food on the Bioavailability of a Single 800 mg Imatinib Dose in Modified Release Formulations (MR3 and MR4) and Compare the Bioavailability Between MR3, MR4 and Imatinib 400 mg Twice Daily Immediate Release Tablet (IR) in Healthy Subjects

This study will evaluate the effect of food on the relative bioavailability of a single dose of imatinib given as a 800 mg modified release tablet, compared to twice-daily doses of 400 mg film-coated tablets. There will be a 8 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.

Inclusion criteria

• Healthy male or female subjects (postmenopausal women), 18-65 years of age
• Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion criteria

• Smokers within 3 months
• Subjects using any prescription drug or over-the-counter (OTC) medication (including herbal and alternative medication) within 3 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
• 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.