Gadobutrol pharmacokinetic and safety study in pediatric subjects aged <2 years (term newborn infants to toddlers 23 months of age inclusive)

Update Il y a 4 ans
Reference: EUCTR2010-023003-96

Woman and Man

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Extract

To evaluate the pharmacokinetics of gadobutrol in plasma at the standard dose of 0.1 mmol/kg body weight in pediatric subjects aged <2 years.


Inclusion criteria

  • Pediatric subjects aged <2 years (term newborn infants to toddlers 23 months of age inclusive) scheduled to undergo routine gadolinium-enhanced MRI of any body region

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