The Bioequivalence Study of Lamotrigine Dispersible/Chewable Tablets 100mg Compared With Compressed Tablet 100 mg
Status:
Completed
Trial end date:
2014-07-08
Target enrollment:
Participant gender:
Summary
This is an open-label, randomised, parallel-group study to demonstrate the bioequivalence of
lamotrigine 100mg in two different formulations, dispersible/chewable tablet and compressed
tablet, in healthy subjects under fasting conditions. Subjects will be randomized in equal
numbers to be dosed with either lamotrigine dispersible/chewable (Test) 100mg tablet or
lamotrigine compressed (Reference) 100mg tablet. Pharmacokinetic blood sampling will be
collected over 216 hours post dose. Safety (tolerability) will be observed up to 216 hours
post dose. Safety assessments will include regular monitoring of vital signs, ECG's, adverse
events (AEs) and safety laboratory tests. A follow-up visit is scheduled within 10-17 days
post-dose.