Phase I Relative Bioavailability and food effect study

Mise à jour : Il y a 4 ans
Référence : EUCTR2016-002895-29

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Extrait

The primary objectives of this study are to -investigate the relative bioavailability of a single oral dose of 1.25 mg finerenone ODT and 5 x 0.25 mg ODT (pediatric formulation) in comparison to 10 mg finerenone (adult formulation) tablet in the fasting condition -investigate the effect of a high fat, high calorie meal on the pharmacokinetics after a single oral dose of 1.25 mg finerenone ODT -investigate whether the finerenone ODTs are palatable and swallowable


Critère d'inclusion

  • Treatment of diabetic kidney disease (adults) and chronic kidney disease
  • (children)

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