An open label, balanced, randomized, two treatments, two sequences, two periods, crossover, single dose, bioequivalence study of lafigin dt (lamotrigine) 200 mg orally dispersible tablets of laboratorios recalcine s.a. Chile and lamictal odt® (lamotrigine) 200 mg orally dispersible tablets of glaxosmithkline llc, in healthy, adult, human subjects under fasting condition - Abstract
Lamotrigine is a phenyltriazine used in the treatment of epilepsy and bipolar disorder type I. The purpose of this study was to evaluate the bioequivalence between Lafigin DT (Lamotrigine) 200 mg orally dispersible Tablets of Laboratorios Recalcine S.A. Chile and LAMICTAL ODT® (Lamotrigine) 200 mg orally dispersible Tablets of Glaxosmithkline LLC in healthy, adult, human subjects. An open label, balanced, randomized, two treatments, two sequences, two periods, crossover, single dose study with washout period of 10 days under fasting condition was carried out in 28 subjects in the age group of 26 to 43 years and 27 subjects completed the study. All the subjects included in the study were males and Asians. The pharmacokinetic samples collected from subjects who completed the study were analysed to determine the plasma concentration of Lamotrigine using a validated
bio-analytical method. The 90% confidence interval of Cmax and AUC0-72 were 87.03% - 106.32% and 84.23% - 100.64%, respectively which were within the acceptable limits for Cmax of 80.00 % to 125.00 %.