Background/aim: To establish bioequivalence of lamotrigine dispersible/chewable (CD) tablets (test) versus compressed tablets (reference).Methods: Three clinical studies were conducted in Chinese healthy male subjects to investigate the bioequivalence of two different tablet formulations of lamotrigine: CD tablet versus compressed tablet.In two open-label, randomised, two-period crossover studies, which were conducted in Hong Kong (NCT01357902) and mainland China (NCT 01879423) separately, subjects received a single dose of lamotrigine CD tablet 5 mg×5 and compressed tablet 25 mg in a randomised order.There were 14 days washout period between two doses.The 3rd study, conducted in mainland China (NCT02064465), was a single dose, open-label,randomized, parallel-group study to demonstrate the bioequivalence of lamotrigine CD tablet (100mg) and compressed tablet (100mg), subject received a single dose of lamotrigine CD tablet 100mg or compressed tablet 100mg.Pharmacokinetic samples were taken for up to 9 days after each dose.Plasma was assayed for lamotrigine concentration by HPLC/MS.Pharmacokinetic data were analyzed by noncompartmental methods using WinNonlin(R) (Pharsight Corporation).Average bioequivalence criteria were applied.Results: 24 and 23 subjects completed the two crossover studies, respectively, while 137 subjects completed the parallel-group study.In all three studies, both lamotrigine DC tablets and compressed tablets were well tolerated.Bioequivalence was demonstrated between lamotrigine CD tablets and compressed tablets based on AUC(0-￥) and Cmax, as all the 90％ confidence intervals of the ration of geometric means fall within the predefined equivalence limits of.Conclusions: Three studies conducted in Chinese healthy male subjects demonstrated that lamotrigine CD tablets were bioequivalent to lamotrigine compressed tablets.Both formulations were well tolerated and the safety assessment did not reveal any safety concerns.Disclosure: These three bioequivalence studies were all funded by GSK.