Randomized, single-dose, two-period, two-sequence crossover bioequivalence study evaluating two oral formulations of lamotrigine in healthy volunteers

Background: Lamotrigine is an anti-epileptic medicine used to treat epilepsy and bipolar disorder. The mechanism of action block voltage activated sodium channels. aim this study was evaluate the bioequivalence 2 oral formulations lamotrigine 25 mg in healthy volunteers.Methods: A single-dose, two-period, randomized crossover design - Indian adult volunteers conducted at Amaris Clinical, a division Caplin Point Laboratories Ltd., Chennai. validated high performance liquid chromatography conjunction with mass spectrometry used. concentration plasma. Adverse events were determined by measuring vital functions after dosing. total 24 subjects included.Results: mean 90% confidence intervals test / reference ratios for these parameters as follows: Cmax Tmax 758.606 (157.453) ng ml 1.17 (0.50-5.00) hours, respectively. 775.993 (151.654) or 0.88 (0.25-4.00) hours. AUC0-72 24142. 031±3641.691 (ng.hr/mL) formulation 24202.099±3742.957 (ng. h ml) formulation. 97.92 99.82 parametric CIs 90.17-105.68% 97.87-101.81%.Conclusions: ranged from 80-125% it concluded that product bioequivalent male volunteers.