Ignite Creation Date:
2024-05-06 @ 2:13 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01995825
Status:
COMPLETED
Last Update Posted:
2020-12-01
First Post:
2013-01-26
Brief Title:
Lamotrigine Bioequivalence
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Evaluation of Bioequivalence of Lamotrigine Tablets in Epileptic Patients
Status:
COMPLETED
Status Verified Date:
2020-11
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:
In this study brand name lamotrigine LAMICTAL and generic lamotrigine will be compared in patients with epilepsy Both the brand name and generic lamotrigine are approved by the Food and Drug Administration FDA and are commonly used to treat epilepsy Some physicians and patients with epilepsy have believed that brand and generic lamotrigine have had clinically significant differences in efficacy and tolerability The brand name and generic tablets have been shown to be the same when blood levels were measured in healthy volunteers without epilepsy but these drugs have not yet been compared in patients with epilepsy This study will do this comparison by switching patients between brand and generic in a very structured manner and seeing if the drugs are the same primarily in terms of blood levels Other comparisons will also be made secondarily looking for any differences in adverse effects and seizure control
Detailed Description:
As is commonly done in a bioequivalence study the null hypothesis is that the generic ie test is bioINequivalent to the brand name ie reference Hence the alternative hypothesis is that the generic is bioequivalent to the brand name
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HHSF223201010144A | OTHER_GRANT | HHS | None |