A Study to Compare How Much of the Study Treatment Finerenone Gets Into the Blood When the Same Amount is Taken in One and in Two Tablets of Different Strengths in Healthy Male Participants

In this bioequivalence study, healthy male participants took the study treatment finerenone in the form of one and two tablets of different strengths by mouth. "Bioequivalence" means that the researchers want to show similar blood levels of finerenone in the participants when they take the one tablet form of finerenone compared to the two tablets form. This study helped researchers learn more about a new finerenone tablet with higher strength, which is being developed to treat people who have heart failure (HF) with left ventricular ejection fraction (LVEF) ≥ 40%. HF with LVEF ≥ 40% is a condition which occurs when the left side of the heart does not pump blood out to the body as well as it should. Over time, the body does not get the amount of oxygen it needs. This can lead to shortness of breath and tiredness, making it harder for people to do their daily tasks. Finerenone works by blocking a certain protein, called mineralocorticoid receptor. By doing this, finerenone reduces damage to kidneys, heart and blood vessels. It is available and approved for doctors to prescribe to people with chronic kidney disease together with type 2 diabetes. The main objective of this study was to compare how much finerenone gets into the blood when the participants took the same amount of finerenone in the form of one and two tablets of different strengths by mouth. Another objective of this study was to learn the degree to which medical problems that might be caused by finerenone can be tolerated (also called "tolerability") by the participants. These medical problems were also known as "adverse events". Doctors kept track of all adverse events that happened in the study, even if they did not think they might be related to the study treatments. The study was conducted in a single-center, randomized, non-blinded, two-way crossover design in healthy male participants aged 18 to 55 years. "Single-center" means at one research center or one hospital. "Randomized" means that the