title: 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.
abstract: Children with gastroesophageal reflux disease (GERD) may benefit from gastric acid suppression with proton pump inhibitors such as pantoprazole. Effective treatment with pantoprazole requires correct dosing and understanding of the drug's kinetic profile in children. The aim of these studies was to characterize the pharmacokinetic (PK) profile of single and multiple doses of pantoprazole delayed-release tablets in pediatric patients with GERD aged 6 to 11 years (study 1) and 12 to 16 years (study 2). Patients were randomly assigned to receive pantoprazole 20 or 40 mg once daily. Plasma pantoprazole concentrations were obtained at intervals through 12 hours after the single dose and at 2 and 4 hours after multiple doses for PK evaluation. PK parameters were derived by standard noncompartmental methods and examined as a function of both drug dose and patient age. Safety was also monitored. Pantoprazole PK was dose independent (when dose normalized) and similar to PK reported from adult studies. There was no evidence of accumulation with multiple dosing or reports of serious drug-associated adverse events. In children aged 6 to 16 years with GERD, currently available pantoprazole delayed-release tablets can be used to provide systemic exposure similar to that in adults.
authors.affiliation: University of Utah Pediatric Pharmacology Research Unit, 417 Wakara, Suite 3510, Salt Lake City, UT 84108, USA. Robert.Ward@hsc.utah.edu
authors.forename: Robert M
authors.initials: RM
authors.lastname: Ward
authors.forename: Gregory L
authors.initials: GL
authors.lastname: Kearns
authors.forename: Brinda
authors.initials: B
authors.lastname: Tammara
authors.forename: Phyllis
authors.initials: P
authors.lastname: Bishop
authors.forename: Molly A
authors.initials: MA
authors.lastname: O'Gorman
authors.forename: Laura P
authors.initials: LP
authors.lastname: James
authors.forename: Mitchell H
authors.initials: MH
authors.lastname: Katz
authors.forename: Mary K
authors.initials: MK
authors.lastname: Maguire
authors.forename: Natalie
authors.initials: N
authors.lastname: Rath
authors.forename: Xu
authors.initials: X
authors.lastname: Meng
authors.forename: Gail M
authors.initials: GM
authors.lastname: Comer
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics*; D000293:Adolescent; D002648:Child; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000493:pharmacokinetics; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005764:Gastroesophageal Reflux / Q000097:blood / Q000188:drug therapy* / Q000235:genetics; D005838:Genotype; D006801:Humans; D008658:Inactivation, Metabolic / Q000235:genetics; D008297:Male; D000077402:Pantoprazole; D054328:Proton Pump Inhibitors / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics*; D013607:Tablets / Q000008:administration & dosage / Q000493:pharmacokinetics
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D003692:Delayed-Action Preparations; D054328:Proton Pump Inhibitors; D013607:Tablets; D000077402:Pantoprazole