Femme et Homme
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Extrait
The objective of the study is to evaluate the pharmacokinetics, pharmacodynamics (clinical global impressions and formulation palatability) and safety of rabeprazole after single and multiple daily administration at 2 dose levels in children between the ages of 1 to 11 years, inclusive (up to 11 years 364 days), with GERD. As this study is an exploratory assessment of the pharmacokinetics, pharmacodynamics, and safety of rabeprazole in children, no formal hypothesis testing is applied.
Critère d'inclusion
- Pediatric subjects with GERD (endoscopically proven) and have had endoscopic examination as part of their diagnostic evaluation; 1 to 11 Years Old, inclusive