Single Dose Comparative Bioavailability Study of Lisdexamfetamine Dimesylate as Oral Solution Versus Reference Hard Capsules in Healthy Volunteers.

ABSTRACT: Lisdexamfetamine is an inactive prodrug of dexamfetamine that is used for the second-line treatment of attention-deficit/hyperactivity disorder (ADHD) and moderate to severe binge eating disorder (BED). Once in the blood, the prodrug is hydrolyzed in erythrocyte cytosol, thus releasing the active dexamfetamine. We here present a fully validated HPLC-MS/MS analytical method for simultaneous determination of lisdexamfetamine and dexamfetamine in human plasma and the first published comparative bioavailability study of lisdexamfetamine including a GMP finished product formulated as oral solution. The Test (T)/Reference (R) ratios for the geometric means (%) of the primary pharmacokinetic (PK) parameters and their corresponding two-sided 90% confidence intervals (CIs) were contained within the

SUBMITTER: Rizea-Savu S 

PROVIDER: S-EPMC9016112 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature