A Randomized, Open-Label, Crossover Comparative Bioavailability Study of Finerenone 20 mg Film-Coated Tablets in Healthy Participants Under Fasting Conditions

The primary objective of this study is to conduct a comparative bioavailability assessment of finerenone 20 mg, administered as Prototype 1 and Prototype 2 film-coated tablets, against the reference product Kerendia 20 mg under fasting conditions. This evaluation is clinically relevant to determine the bioequivalence of the prototype formulations to the established medicinal product. 8

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including both males and females. The participants belong to an age range categorized under code 3. The study population includes vulnerable individuals.

This Phase 3, randomized, open-label, laboratory-blinded, balanced, single-dose, 3-treatment, 6-sequence, 3-period crossover comparative bioavailability study is designed to evaluate finerenone (20 mg film-coated tablets, Prototype 1 and Prototype 2) and kerendia (20 mg film-coated tablets) under fasting conditions in healthy participants. The research methodology utilizes a crossover design to assess the pharmacological properties of the specified treatments. The study involves several stages, including a screening visit to determine eligibility, followed by multiple treatment periods and subsequent follow-up visits. The procedure concludes with an end-of-study visit. The total duration of participant involvement is determined by the completion of the three treatment periods and necessary monitoring phases. Early termination from the study may occur based on predefined clinical criteria or protocol deviations.

The assessment of efficacy in this study is focused on a comparative bioavailability evaluation conducted under fasting conditions.