Study title: Open-label, randomized, three-way, cross-over single-center study to Prove the equivalence of a single dose of Creon® 10,000 Minimicrospheres™ and Pancrease by using the 13C-mixed triglyceride breath test in patients with pancreatic exocrine insufficiency due to cystic fibrosis
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: Pancreatin | |||||
ATC code: | |||||
Document link: Pancreatin-S245-3111.pdf | |||||
Document date: 2011-10-19 | |||||
Study number: S245-3111 | |||||
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) |
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