Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00420043
Status:
COMPLETED
Last Update Posted:
2016-04-05
First Post:
2007-01-08
Brief Title:
Effect of Food on Bioavailability of Modified Release Formulations of Imatinib
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
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
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None