Ignite Creation Date:
2024-05-06 @ 3:53 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02404168
Status:
COMPLETED
Last Update Posted:
2019-08-19
First Post:
2015-03-17
Brief Title:
BEEP Follow Up Evaluation of Repeatability of Lamotrigine Pharmacokinetics in Epileptic Patients
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Evaluation of Repeatability of Lamotrigine Pharmacokinetics in Epileptic Patients
Status:
COMPLETED
Status Verified Date:
2019-08
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 prior BEEP study involved patients being switched between brand and generic in a very structured manner Other secondary comparisons were also made ie any differences in adverse effects and seizure control Some subjects were more disparate than other in terms of generic being similar to brand In this follow up study BEEP subjects that showed disparate results will be tested again to assess reproducibility of disparate results
Detailed Description:
This is an double-blind multiple-dose full replicate design pharmacokinetic study of lamotrigine in enriched patients with epilepsy who previously participated in HP-00048923 LAMICTAL 100mg tablets and the most commonly used generic lamotrigine 100mg tablet from Teva will be compared pharmacokinetically
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None