NCT00422825
Completed
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- imatinib
- Conditions
- Healthy
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 16
- Primary Endpoint
- Assess the effect of food on bioavailability and pharmacokinetics of modified and immediate release formulations of imatinib
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Imatinib 400mg
Intervention: imatinib
Imatinib 800mg
Intervention: imatinib
Outcomes
Primary Outcomes
Assess the effect of food on bioavailability and pharmacokinetics of modified and immediate release formulations of imatinib
Secondary Outcomes
- 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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