Trial Condition(s):

Diabetic Kidney Disease

Pilot bioavailability study with finerenone

Bayer Identifier:

19092

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2017-001776-37

Study Completed

Trial Purpose

The primary objective of the study was to
• investigate the relative bioavailability of 20 mg finerenone tablet manufactured in a continuous process (ConsiGma) in comparison to 20 mg finerenone tablet manufactured in a batch process (i.e. the current Phase 3 formulation) in the fasting condition
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 (inclusive), Body mass index (BMI): ≥ 18.0 and ≤ 29.9 kg/m²
Exclusion Criteria
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
16
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
No
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteers
Yes

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

CRS Clinical-Research-Services Mönchengladbach GmbH

Mönchengladbach, Germany, 41061

Status
Completed
 

Trial Design