Overview

The Bioequivalence Study of Lamotrigine Dispersible/Chewable Tablets 5mg×5 Compared With Lamotrigine Compressed Tablet 25mg in Chinese Healthy Male Subjects

Status:
Completed

Trial end date:
2013-06-06

Target enrollment:

Participant gender:

Summary

This is a single dose, open-label, randomized, two-period crossover study to demonstrate the bioequivalence of lamotrigine dispersible/chewable tablets (5mg×5) and lamotrigine compressed tablets (25mg) in healthy Chinese male subjects in fasting conditions. The safety, tolerability and pharmacokinetic profile of lamotrigine dispersible/chewable tablets will also be assessed.

Phase:

Phase 1

Details

Lead Sponsor:

GlaxoSmithKline

Treatments:

Anticonvulsants
Lamotrigine