Effect of Food on Bioavailability of a Modified Release Formulation of Imatinib
- Registration Number
- NCT00422825
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Imatinib 800mg imatinib - Imatinib 400mg imatinib -
- Primary Outcome Measures
Name Time Method Assess the effect of food on bioavailability and pharmacokinetics of modified and immediate release formulations of imatinib
- Secondary Outcome Measures
Name Time Method 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 To compare safety and tolerability of 800 mg modified release formulation with or without food.