A Pharmacokinetic, Pharmacodynamic and Short-term Safety Study of Single and Multiple Day Doses of Rabeprazole Sodium in Neonates and Pre-term Infants with a Corrected Age of Less than 44 Weeks with a Presumptive Diagnosis of GERD

Femme et Homme

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Extrait

The objective of this study is to evaluate the pharmacokinetics (PK) using population PK methods, pharmacodynamics (PD) (intraesophageal and intragastric pH, assessment of the overall treatment effect [OTE] [overall GERD symptom relief]) and the short-term safety of rabeprazole after single and multiple dose administration for up to 28 days at one low dose level (Part 1) and two presumed effective dose levels (Part 2) in neonates and pre-term infants, with a corrected age of less than 44 weeks at the time of the first dose, who have been diagnosed with GERD. As this study is an exploratory assessment of the population PK, PD and short-term safety of rabeprazole in neonates and pre-term infants, no formal hypothesis testing is applied.

Critère d'inclusion

Gastroesophageal reflux disease (GERD) in neonates and pre-term infants, with a corrected age of less than 44 weeks at the time of the first dose

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A Pharmacokinetic, Pharmacodynamic and Short-term Safety Study of Single and Multiple Day Doses of Rabeprazole Sodium in Neonates and Pre-term Infants with a Corrected Age of Less than 44 Weeks with a...