Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00260247
Status:
COMPLETED
Last Update Posted:
2015-04-22
First Post:
2005-11-28
Brief Title:
Induction of Drug Metabolism In Vivo Comparison of Carbamazepine and Oxcarbazepine
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Induction of Drug Metabolism A Comparative Pharmacokinetic in Vivo Study of the Effect of Carbamazepine and Oxcarbazepine on CYP3A4
Status:
COMPLETED
Status Verified Date:
2005-03
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 is a study of the possible effect of two antiepileptic drug on enzymes in the liver that metabolizes a number of drugs It is a well know fact that carbamazepine induces some of these enzymes and this may reduce the effect of concomitantly administered drugs Clinical observations suggest that oxcarbazepine does not induce these enzymes to the same degree
This study directly compares the ability of these two drugs to induce the cytochrome P450 3A4 enzyme in healthy volunteers using a well defined biomarker reaction of a specific enzyme activity
It is the hypothesis that oxcarbazepine induces CYP3A4 to a lesser degree than carbamazepine
This study directly compares the ability of these two drugs to induce the cytochrome P450 3A4 enzyme in healthy volunteers using a well defined biomarker reaction of a specific enzyme activity
It is the hypothesis that oxcarbazepine induces CYP3A4 to a lesser degree than carbamazepine
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