Bioequivalence study of sodium valproate/valproic acid 500 mg tablets

INTERVENTION: Intervention 1: Intervention group 1: Oral administration of a single 500 mg dose of valproate (1 tablet) manufactured by Ronak to healthy volunteers under fasting condition in the morning of the experiment day. Intervention 2: Intervention group 2: Oral administration of a single 500 mg dose of Depakin (1 tablet) manufactured by Sanofi to healthy volunteers under fasting condition in the morning of the experiment day. CONDITION: .. PRIMARY OUTCOME: Drug plasma concentration. Timepoint: At time zero and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 and 96 h after drug administration. Method of measurement: Blood sampling and measurement of drug concentrations by high‐performance liquid chromatography. SECONDARY OUTCOME: Plasma half‐life. Timepoint: From the sampling time points of 12, 24, 48, 72 and 96 hours of drug plasma concentration‐time profile. Method of measurement: Blood sampling and drug analysis by high‐performance liquid chromatography method. INCLUSION CRITERIA: 18‐55 years of age. The subject is able and willing to provide signed informed consent. Willing to adhere to protocol requirements as evidenced by written informed consent. The subject has a stable residence and telephone. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.