Ignite Creation Date:
2024-05-05 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 9:44 AM
Study NCT ID:
NCT00618046
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2008-01-31
Brief Title:
Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions
Sponsor:
Roxane Laboratories
Organization:
West-Ward Pharmaceutical
Study Overview
Official Title:
A Single Dose 2-Period 2-Treatment 2-Way Crossover Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions
Status:
COMPLETED
Status Verified Date:
2018-01
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 objective of this study was to assess bioequivalence of a potential generic 600 mb oxcarbazepine tablet formulation compared with Novartis Pharmaceuticals 600 mg oxcarbazepine tablet Trileptal following a single 600 mg dose administered with food
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