Study to Investigate the Effect of Deferasirox on the Pharmacokinetics of Midazolam
Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00427505
Collaborator
(none)
22
Study Details
Study Description
Brief Summary
This is a study to investigate the pharmacokinetics of deferasirox
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, One-sequence Cross-over Study to Investigate the Effect of Deferasirox on the Pharmacokinetics of Midazolam in Healthy Volunteers
Study Start Date
:
Jul 1, 2006
Outcome Measures
Primary Outcome Measures
- To assess the effect of deferasirox on the pharmacokinetics of midazolam []
Secondary Outcome Measures
- Safety assessed by adverse events (AEs) []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Good health
-
No evidence of iron deficiency
-
Weight between 50 and 100 kg
-
Body Mass Index between 19 and 29 kg/m2
Exclusion Criteria:
- Use of certain drugs, herbal remedies or nutrients
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Novartis
Investigators
- Study Chair: Novartis, Novartis
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00427505
Other Study ID Numbers:
- CICL670A2126
First Posted:
Jan 29, 2007
Last Update Posted:
Nov 19, 2009
Last Verified:
Nov 1, 2009
Keywords provided by ,
,
Additional relevant MeSH terms: