Combined Immediate-Release and Extended-Release Formulation of Sodium Valproate Provides Stable Plasma Levels for Inhibition of Histone Deacetylation.

ABSTRACT: A modified controlled-release sodium valproate formulation (VAL001, test) was compared with an approved enteric-coated tablet formulation (Absenor, reference). Pharmacokinetics and safety/tolerability were evaluated in healthy subjects to bridge with positive efficacy results from an early-phase patient trial of valproate in combination with chemotherapy in diffuse large B-cell lymphoma. In Part I (n = 12), both formulations were administered as single doses (30 mg/kg) in a randomized crossover fashion. Equivalent exposures (area under the plasma concentration-time curve) for total and free valproate were observed under fasted conditions. Intake with food delayed the absorption of valproate from the test formulation, with no impact on AUC. In Part II (n = 27), both formulations were admini

SUBMITTER: Ahuja N 

PROVIDER: S-EPMC12402831 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature