Study title: Study of the pharmacokinetic linearity of three paediatric doses of paracetamol (50, 125, and 250mg) administered as a new Synthelabo formulation, and their bioequivlence with a standard formulation of DOLIPRANE dosed at 16mg healthy male young volunteers. Open, randomised, cross-over and single-center study.
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Anesthesia and Analgesia | |||||
Brands: Please see report, Please see report | |||||
MAH holders: Please see report, Please see report, Please see report | |||||
Assessment: | |||||
Active substance: PARACETAMOL | |||||
ATC code: | |||||
Document link: 2890 98 FR 001.pdf | |||||
Document date: 2011-09-12 | |||||
Study number: 2890 98 FR 001 | |||||
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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