NCT07133399

A Study in Healthy People to Test How 2 Different Formulations of a Combination Treatment (Vicadrostat and Empagliflozin) Are Taken up in the Body and How Food Influences the Amount of the Medicines in the Blood

Relative Bioavailability of Two Different Vicadrostat/ Empagliflozin Combinations and Investigation of the Effect of Food on the Pharmacokinetics of a Vicadrostat/ Empagliflozin Combination in Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Three- Way Crossover Study)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To investigate the relative bioavailability of two different vicadrostat/empagliflozin combinations. Additionally, the trial investigates the effect of food on the pharmacokinetics of the vicadrostat/empagliflozin.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	vicadrostat / empagliflozin combination 1	vicadrostat / empagliflozin combination 1
DRUG	vicadrostat / empagliflozin 2	vicadrostat / empagliflozin 2

Timeline

• Start date: 2025-09-08
• Primary completion: 2025-10-22
• Completion: 2025-10-22
• First posted: 2025-08-21
• Last updated: 2026-01-06

Locations

1 site across 1 country: Germany