Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424671
Status:
COMPLETED
Last Update Posted:
2007-06-22
First Post:
2007-01-18
Brief Title:
Effect of Moderate Hepatic Impairment on the Pharmacokinetics and Metabolism of a Single Dose of Licarbazepine
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
An Open-Label Study in Healthy Subjects and in Subjects With Stable Impaired Hepatic Function to Assess the Effect of Moderate Hepatic Impairment on Licarbazepine Pharmacokinetics and Metabolism After a Single Dose of 1000 mg Licarbazepine IR Tablets
Status:
COMPLETED
Status Verified Date:
2007-06
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 assess the influence of moderate hepatic impairment on the pharmacokinetics of licarbazepine after single oral administration in healthy subjects and in subjects with stable impaired hepatic function
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