Bioequivalence of sodium valproate tablets manufactured in Iran compared to its foreign counterpart

    In this double blind crossover study we assessed the bioequivalence of 200 mg enteric coated sodium valproate tablets manufactured by Roozdarou with 200 mg enteric coated sodium valproate (Orlept) manufactured by Desitin, Germany. Twelve healthy male volunteers were administered a single dose of 600 mg sodium valproate manufactured by Roozdarou, followed by a similar dose of Orlept, 2 weeks later. During the first 48 hours following each administration, 11 blood samples were obtained from each volunteer. Plasma levels of valproate were measured with a sensitive and selective HPLC method. Pharmacokinetic parameters were calculated for each administration to determine the bioequivalence of the two products, including maximum plasma concentration (Cmax), time to attain maximum plasma concentration (Tmax), and area under the plasma concentration-time curve (AUC). Comparison of these figures demonstrated no significant difference therefore 200 mg enteric coated sodium valproate tablets manufactured by Roozdarou are bioequivalent to 200 mg enteric coated Orlept tablets.