Study title: Open, single-dose, phase i study to evaluate the pharmacokinetic parameters of pentoxyverine and its major metabolites in plasma and urine of children with upper respiratory tract infection.
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Respiratory Tract Diseases | |||||
Brands: Please see report | |||||
MAH holders: Please see report, Please see report | |||||
Assessment: | |||||
Active substance: PENTOXYVERINE | |||||
ATC code: R05DB05 | |||||
Document link: 9738 - Pentoxyverine - MRCE99K0801.pdf | |||||
Document date: 2011-11-28 | |||||
Study number: MRCE99K0801 | |||||
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) |
- | - | - | - | - |