A multicenter, randomized, open-label, pharmacokinetics and safety study of pantoprazole tablets in children and adolescents aged 6 through 16 years with gastroesophageal reflux disease.

摘要: Children with gastroesophageal reflux disease (GERD) may benefit from gastric acid suppression proton pump inhibitors such as pantoprazole. Effective treatment pantoprazole requires correct dosing and understanding of the drug's kinetic profile in children. The aim these studies was to characterize pharmacokinetic (PK) single multiple doses delayed-release tablets pediatric patients GERD aged 6 11 years (study 1) 12 16 2). Patients were randomly assigned receive 20 or 40 mg once daily. Plasma concentrations obtained at intervals through hours after dose 2 4 for PK evaluation. parameters derived by standard noncompartmental methods examined a function both drug patient age. Safety also monitored. Pantoprazole independent (when normalized) similar reported adult studies. There no evidence accumulation reports serious drug-associated adverse events. In children GERD, currently available can be used provide systemic exposure that adults.