Bioequivalence Study of 200 mg Lamotrigine Tablet Under Non-Fasting Conditions
Summary
The objective of this study is to compare the rate and extent of absorption of lamotrigine 200 mg tablets (test) versus Lamictal® (reference) administered as 1 x 200 mg tablet under fed conditions.
Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study Design
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Conditions
Healthy
Intervention
Lamotrigine, Lamictal®
Location
Anapharm Inc.
Sainte-Foy
Quebec
Canada
G1V 2K8
Status
Completed
Source
Teva Pharmaceuticals USA
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00835263
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Clinical Trials
Double-Blind Lamictal (Lamotrigine) in Neurotic Excoriation
The goal of the proposed study is to evaluate the comparative efficacy of Lamictal (lamotrigine) to placebo in neurotic excoriation. Thirty subjects with neurotic excoriation will receive...
Food Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mg
The objective of this study was to investigate the bioequivalence of Mylan's lamotrigine 25 mg tablets to GlaxoSmithKline's (GSK) Lamictal® 25 mg tablets following a single, oral 50 mg (2...
Fasting Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mg
The objective of this study was to investigate the bioequivalence of Mylan's lamotrigine 25 mg tablets to GlaxoSmithKline's (GSK) Lamictal® 25 mg tablets following a single, oral 50 mg (2...
Bioequivalence Study of 200 mg Lamotrigine Tablet Under Fasting Conditions
This is a bioequivalence study to compare the rate and extent of absorption of lamotrigine (test) and Lamictal® (reference)administered as a 1 x 200 mg tablet under fasting conditions.
Lamotrigine 25 mg Chewable Tablets, Non-Fasting
The objective of this study is to compare the rate and extent of absorption of lamotrigine 25 mg chewable dispersible tablets (test) versus Lamictal® (reference) administered as 2 x 25 mg...
PubMed Articles
Lamotrigine is an anti-epileptic drug used as adjunct therapy for seizures. Lamotrigine is commonly used in pregnant women with epilepsy, a population in which therapeutic drug monitoring (TDM) is use...
AIM: Lamotrigine is a neuroprotective agent that is used clinically for the treatment of seizures and neuropathic pain. A significant volume of literature has reported that lamotrigine exerts analgesi...
PURPOSE: This study assessed the comparative efficacy of pregabalin for refractory partial seizures. METHODS: Four-hundred and thirty-four patients with partial seizures were randomized to pregabalin,...
Serum levels of lamotrigine during delivery in mothers and their infants.
PURPOSE: We followed up lamotrigine transport through the placenta and analyzed maternal and umibilical cord concentrations, its ratio and maternal lamotrigine clearance in monotherapy and in combinat...
Brain-derived neurotrophic factor signalling mediates antidepressant effects of lamotrigine.
The anticonvulsant drug lamotrigine has been shown to produce antidepressant effects in patients with bipolar disorder. To date, only a few preclinical studies have been conducted using lamotrigine tr...
