Lamotrigine Bioequivalence Study to Compare Dispersible Tables With Compressed Tablets in China

Epilepsy Clinical Trial

Official title: An Open Label, Randomized, Cross-Over Study to Investigate the Single Dose Bioequivalence of Lamotrigine Dispersible/Chewable Tablets (5mg) Compared to Lamotrigine Compressed/Standard Tablets (25mg) in Chinese Healthy Male Subjects

Status Completed

Clinical Trial Summary

It is an open-label, randomised, single dose, two-sequence cross-over study. Twenty-four eligible, healthy, Chinese male subjects will be enrolled after providing written informed consent. Subjects will be randomised into two treatment groups 1 day prior to the first dosing day and will be assigned to regimen sequences (AB or BA) in a balanced fashion in accordance with the randomisation schedule. Regimen A is five lamotrigine 5 mg chewable/dispersible tablets and Regimen B is one lamotrigine 25 mg standard/compressed tablet.

Subjects will receive their allocated regimen on the morning of Day 1 and will undergo study assessments for 7 days (until Day 8). Subjects will receive their alternate randomised treatment after a washout period of 14-21 days from Day 1. Subjects will undergo a further assessment period of 7 days and will attend a follow-up visit during 8-12 days after the second treatment. The total observation period in this study will be 23~34 days.

Subjects will arrive at the research unit on the evening before each lamotrigine dosing occasion and will remain in the unit until the 24-h post-dose evaluations have been completed (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 h). After this, subjects will return home but must return to the unit for further assessments to be made at 36, 48, 72, 96, 120, 144 and 168 h after dosing Study Endpoints/Assessments A total of 19 serial blood samples (5 mL each) will be collected for the measurement of plasma lamotrigine concentrations at each study assessment. Safety and tolerability assessments (monitoring of adverse events and serious adverse events, routine laboratory determinations, vital sign measurements and 12-lead electrocardiogram) will be conducted throughout the study.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Epilepsy

• NCT number: NCT01357902
• Study type: Interventional
• Source: GlaxoSmithKline
• Status: Completed
• Phase: Phase 1
• Start date: April 18, 2011
• Completion date: May 23, 2011