Study title: Single and Multiple Dose Pharmacokinetics and Safety Study of Rabeprazole Sodium in 12 to 16 Year Old Subjects
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Digestive System Diseases | |||||
Brands: | |||||
MAH holders: | |||||
Assessment: | |||||
Active substance: RABEPRAZOLE | |||||
ATC code: A02B C04 | |||||
Document link: Rabeprazole-E3810-A001-119 CSR synopsis.pdf | |||||
Document date: 2011-10-18 | |||||
Study number: E3810-A001-119 | |||||
EudraCT number: | |||||
Scope of study: Clinical | |||||
Population of study subjects: | Preterm newborn Infants | Newborn infants (1 to 27 days) | Infants and toddlers (28 days to 24 months) | Children (2 to 11 years) | Adolescents (12 to 18 years) |
- | - | - | - | Y |