Randomized, Open-Label, Multicentre Pharmacokinetic Studies of Two Dose Levels of Pantoprazole Granules in Infants and Children Aged 1 Month through <6 Years with Gastro-Oesophageal Reflux Disease

Background and Objective: The primary objective of this study was to characterize the pharmacokinetic profile of pantoprazole delayed-release granules in infants and children aged 1 month to <6 years with gastro-oesophageal reflux disease (GORD). The studies described in this manuscript were conducted to fulfil the requirements of the paediatric written request for pantoprazole by the US FDA.