Study title: Double-Blind, Randomized Trial of the Pharmacokinetics of Dexecadotril (BP 1.01) and Racecadotril (BP 0.52) in Children One Month to Six Years Old Suffering From Acute Diarrhea (Ben Becher S)
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Digestive System Diseases | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: RACECADOTRIL | |||||
ATC code: A07XA04 | |||||
Document link: | |||||
Document date: | |||||
Study number: P.99-03 / BP1.01 | |||||
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 | Y | - |