The Bioequivalence Study of Lamotrigine Dispersible/Chewable Tablets 100mg Compared With Compressed Tablet 100 mg

Epilepsy Clinical Trial

Official title: A Single-Dose, Open-Label, Randomized, Parallel-Group Study to Demonstrate the Bioequivalence of Lamotrigine Dispersible/Chewable Tablet (100mg) and Lamotrigine Compressed Tablet (100mg) in Healthy Chinese Male Subjects

Status Completed

Clinical Trial 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.

Clinical Trial Description

This is a single dose, open-label, randomized, parallel-group study to demonstrate the bioequivalence of lamotrigine dispersible/chewable tablet and lamotrigine compressed tablet at 100mg in healthy Chinese male subjects in fasting conditions. Approximate 138 Chinese healthy male subjects will be enrolled in accordance with the inclusion and exclusion criteria. Subjects will be 18 to 45 years, healthy and body mass index between 19-24 kg/m2 and sign the informed consent.

Having given written informed consent, subjects will be required to undergo a pre-study medical screen within 14 days of the dosing day. Subjects will be admitted on Day 0 (the day before dosing) and will stay in the unit until after the 24-hour post-dose assessments on Day 2. The time that a subject is discharged from the unit may be agreed with unit staff but subjects must return for all designated pharmacokinetic (PK) samples and on scheduled time for observation.

The subjects will be randomized in equal numbers to be dosed under fasting conditions with either lamotrigine dispersible/chewable tablet or lamotrigine compressed tablet. The pharmacokinetic assessment will last 10 days. The blood samples will be collected immediately before dosing (pre-dose) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 and 216 hours post dose for determination of lamotrigine concentration in blood. Safety and tolerability evaluation will be observed up to 216 hours post-dose, including adverse events, vital signs, physical examination, electrocardiogram. All subjects will be required to undergo a follow-up assessment within 10-17 days after receiving the study medication. ;

Related Conditions & MeSH terms

• Epilepsy

• NCT number: NCT02064465
• Study type: Interventional
• Source: GlaxoSmithKline
• Status: Completed
• Phase: Phase 1
• Start date: March 15, 2014
• Completion date: July 8, 2014