Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00419172
Status:
COMPLETED
Last Update Posted:
2009-11-19
First Post:
2007-01-04
Brief Title:
Effect of a Potent Inducer Rifampicin on the Pharmacokinetics of Deferasirox in Healthy Volunteers
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
A Phase I Single Center Open-label One-sequence Cross-over Study to Investigate the Effect of a Potent Inducer Rifampicin on the Pharmacokinetics of Deferasirox in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2009-11
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:
The study will consist of two open-label periods a Treatment Period I deferasirox and a Treatment Period II rifampicindeferasirox At least 18 subjects are expected to complete both treatment periods as per protocol For all subjects in addition to the two treatment periods there will be a 21 day screening period one baseline evaluation the day preceding deferasirox administration in Treatment Period I and an end-of-study evaluation EOS Study subjects will be required to remain in the unit from Day -1 until Day 17 EOS evaluation final safety assessment will be performed 7-10 days after the last dose of rifampicin
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