Phase I relative bioavailability and food effect study

Registry ID
EUCTR2016-002813-24
Source registry
EUCTR
Status
Completed
Phase
PHASE1
Sponsor
Bayer AG
Start date
2016-11-15
Completion date
2017-03-01
Last update
2026-08-16

Conditions

Summary

The primary objectives of this study are to •investigate the relative bioavailability of a single oral dose of 20 mg finerenone suspension and 20 mg crushed and resuspended tablet in comparison to 20 mg finerenone 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 finerenone suspension •investigate whether 20 mg finerenone suspension and 20 mg crushed and resuspended tablet are palatable and swallowable

Locations

View on source registry