Study title: An open-label, multicenter, single-dose study to evaluate the pharmacokinetics of glimepiride (Amaryl®) in pediatric patients with type 2 diabetes mellitus - Sponsor Sanofi - 26/02/2004
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Nutritional and Metabolic Diseases [C18] | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: GLIMEPIRIDE | |||||
ATC code: | |||||
Document link: Glimepiride-Study 2.pdf | |||||
Document date: 2011-09-23 | |||||
Study number: HOE 490/4045 | |||||
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 |