Study title: Pharmacokinetics, safety, and tolerability of single oral doses (0.1, 0.2, 0.4 and 0.8 mg) of tamsulosin hydrochloride in children with voiding disorders
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Urigenital diseases C12 and C14 | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: TAMSULOSIN | |||||
ATC code: G04CA02 | |||||
Document link: Tamsulosin_U05-3269_synopsis.pdf | |||||
Document date: 2011-09-07 | |||||
Study number: U05-3269 | |||||
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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