drugset / Trial / NCT00422825

Effect of Food on Bioavailability of a Modified Release Formulation of Imatinib

NCT00422825

Phase 1 Completed 16 enrolled Novartis Pharmaceuticals
RandomizedCrossoverOpen-labelTreatment

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

Timeline

Start
2006-06
Primary completion
2006-09
Completion
2006-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Imatinib Small molecule 400 mg
Subject Imatinib Small molecule 800 mg

Indications

No indication recorded.