Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410371
Status:
COMPLETED
Last Update Posted:
2017-09-12
First Post:
2006-12-11
Brief Title:
Study to Compare Two Formulations of Lamotrigine in Healthy Subjects
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
An Open-label Randomised Single-dose Parallel-group Study to Evaluate the Pharmacokinetic Characteristics Safety and Tolerability of up to Two Formulations With Different Taste Masking Approaches of an Orally Disintegrating Tablet ODT of Lamotrigine at 25mg and 200mg Versus the Immediate Release IR Lamotrigine in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2017-09
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 intends to compare the pharmacokinetic characteristics safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers
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