Trials / Completed
CompletedNCT00420043
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Novartis · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | imatinib |
Timeline
- Start date
- 2006-09-01
- Primary completion
- 2006-11-01
- Completion
- 2006-11-01
- First posted
- 2007-01-09
- Last updated
- 2016-04-05
Source: ClinicalTrials.gov record NCT00420043. Inclusion in this directory is not an endorsement.