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

Epilepsy Clinical Trial

Official title: A Single-Dose, Open-Label, Randomized, Two-Period Crossover Study to Demonstrate the Bioequivalence of Lamotrigine Dispersible/Chewable Tablets (5mg×5) and Lamotrigine Compressed Tablet (25mg) in Healthy Chinese Male Subjects.

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. 24 healthy Chinese male subjects will be enrolled to provide data from at least 22 evaluable subjects . In Period 1, subjects will be randomized in equal numbers to be dosed with either lamotrigine dispersible/chewable 5mg×5 tablets or lamotrigine compressed tablet 25mg×1. Following a washout of at least 14 days, subjects will be crossed over in Period 2 to receive the treatment that they did not receive in Period 1.

Pharmacokinetic blood samples will be collected over 168 hours post dose. Venous blood (2 ml each) is taken immediately before dosing (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post dose to determine the lamotrigine concentration in serum. Drug concentration in serum at different time points will be determined for each subject with a validated bioanalytical method using LC/MS/MS method. The main pharmacokinetic parameters such as Cmax, tmax, AUC(0-inf), AUC(0-t), t1/2, λz, CL/F and Vd/F are calculated for subjects using non-compartment analysis method.

Physical examination, electrocardiogram and clinical laboratory tests are conducted at screening and 168 hours after administration of each dose; vital signs are measured at scheduled time; adverse events are recorded throughout the study. Clinically relevant safety measurement values are tabulated to evaluate the safety and tolerability of lamotrigine dispersible/chewable tablet. Safety evaluation lasts up to 168 hours after the second oral administration. ;

Related Conditions & MeSH terms

• Epilepsy

• NCT number: NCT01879423
• Study type: Interventional
• Source: GlaxoSmithKline
• Status: Completed
• Phase: Phase 1
• Start date: April 28, 2013
• Completion date: June 6, 2013