Trial Condition(s):

Diabetic Kidney Disease

Relative Bioavailability and food effect study with finerenone

Bayer Identifier:

16536

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2016-000057-12

Study Completed

Trial Purpose

The primary objectives of the study were to
• investigate the pharmacokinetic dose proportionality of a single oral dose of 10 mg tablet in comparison to 20 mg tablet in the fasting condition
• investigate the effect of a high fat, high calorie meal on the pharmacokinetics after a single oral dose of 20 mg tablet
The secondary objective of this study was to investigate the safety and tolerability of single oral doses of finerenone.

Inclusion Criteria
- Healthy male white subjects, 18 to 45 years of age, BMI: ≥ 18.0 and ≤ 29.9 kg/m^2
Exclusion Criteria
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
18
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteers
Yes

Where to Participate

Locations
Status
LocationsStatus

Trial Design