Relative Bioavailability Study to Investigate the Pharmacokinetics, Safety and Tolerability of Single Oral Doses of Finerenone 1.25 mg and 5 x 0.25 mg Orodispersible Tablet (Pediatric Formulation) in Comparison to 10 mg Tablet (Adult Formulation) in the Fasting Condition and to Investigate the Effect of a High Fat, High Calorie Meal on 1.25 mg Oro-dispersible Tablet in Healthy Male Subjects in a Randomized, Open-label, Four-fold Crossover Design.

Trial Profile

Relative Bioavailability Study to Investigate the Pharmacokinetics, Safety and Tolerability of Single Oral Doses of Finerenone 1.25 mg and 5 x 0.25 mg Orodispersible Tablet (Pediatric Formulation) in Comparison to 10 mg Tablet (Adult Formulation) in the Fasting Condition and to Investigate the Effect of a High Fat, High Calorie Meal on 1.25 mg Oro-dispersible Tablet in Healthy Male Subjects in a Randomized, Open-label, Four-fold Crossover Design.

Completed
Phase of Trial: Phase I

Latest Information Update: 17 Apr 2017

At a glance

  • Drugs Finerenone (Primary)
  • Indications Chronic heart failure; Diabetic nephropathies
  • Focus Pharmacokinetics
  • Sponsors Bayer
  • Most Recent Events

    • 04 Apr 2017 Status changed from active, no longer recruiting to completed.
    • 03 Jan 2017 Status changed from recruiting to active, no longer recruiting.
    • 01 Dec 2016 Status changed from not yet recruiting to recruiting.
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