Finerenone is developed for the treatment of diabetic kidney disease (adults) and chronic kidney disease (children). The purpose of the proposed trial is to test the pharmacokinetics of a single oral dose of finerenone (1.25 mg tablet and 5 x 0.25 mg tablets) using a novel orodispersible tablet formulation for the treatment of children, in comparison to the adult tablet formulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
16
10 mg finerenone immediate-release tablet; single dose in the fasting condition
5 x 0.25 mg (1.25 mg) oro-dispersible tablets; single dose in the fasting condition
1.25 mg finerenone oro-dispersible tablets; single dose in the fasting condition or in the fed condition
Unnamed facility
Mönchengladbach, North Rhine-Westphalia, Germany
Finerenone area under the plasma concentration vs. time curve (AUC)
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5. 3, 4, 6, 8, 12, 15 and 24 hours
Finerenone maximum plasma concentration (Cmax)
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5. 3, 4, 6, 8, 12, 15 and 24 hours
Appearance of oro-dispersible tablets assessed by questionnaire
Time frame: Up to 5 minutes after drug administration
Taste of oro-dispersible tablets assessed by questionnaire
Time frame: Up to 5 minutes after drug administration
Texture of oro-dispersible tablets assessed by questionnaire
Time frame: Up to 5 minutes after drug administration
Smell of oro-dispersible tablets assessed by questionnaire
Time frame: Up to 5 minutes after drug administration
Overall impression of oro-dispersible tablets assessed by questionnaire
Time frame: Up to 5 minutes after drug administration
Whether oro-dispersible tablets are palatable and swallowable assessed by questionnaire
Time frame: Up to 5 minutes after drug administration
Number of patients with adverse events as a measure of safety and tolerability
Time frame: Up to 3 weeks
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