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

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.

本研究为一项开放标签、随机平行分组临床试验，旨在评估健康受试者空腹状态下两种100mg拉莫三嗪（lamotrigine）制剂的生物等效性，两种制剂分别为分散片/咀嚼片与压片。受试者将按1:1比例随机分组，分别接受100mg拉莫三嗪分散片/咀嚼片（试验制剂）或100mg拉莫三嗪压片（参比制剂）给药。给药后216小时内将采集血样用于药代动力学分析，同时对安全性（耐受性）进行观察。安全性评估包括定期监测生命体征、心电图（ECG）、不良事件（AEs）及安全性实验室检查。给药后10-17天内将安排一次随访访视。