Global Trace Module in The Effect of Obesity on the Pharmacokinetics of Pantoprazole in Children and Adolescents

Global Trace Module data
Study Description
This was a prospective, multi-center, open-label pharmacokinetic (PK) and safety study of pantoprazole in obese children 6 to 17 years of age requiring treatment with an acid-modifying agent. The primary objective was to evaluate the PK of pantoprazole following administration of a single oral dose. All enrolled participants received study medication, were included in the safety population, and submitted at least one fresh plasma PK sample. The PK of pantoprazole was affected by obesity, with higher exposures observed in obese children and adolescents relative to non-obese historical controls. However, if weight tiered dosing regimens are used according to the FDA label, obese children and adolescents may be given the same dose as non-obese peers. Pantoprazole was well tolerated in this open-label study, with 9 AEs reported in 7 (17%) of the 41 safety participants during the study. Two AEs (headache and hiccups) in 2 participants (5%) were considered related to study drug. No SAEs were reported. Male and female children and adolescents, ranging in age from 6–17 years (inclusive) with the diagnosis of gastroesophageal reflux disease (GERD)