Relative bioavailability study to investigate the pharmacokinetics, safetyand tolerability of single oral doses of finerenone 1.25 mg and 5 x 0.25 mgoro-dispersible tablet (pediatric formulation) in comparison to 10 mgtablet (adult formulation) in the fasting condition and to investigate theeffect of a high fat, high calorie meal on 1.25 mg oro-dispersible tablet inhealthy male subjects in a randomized, open-label, four-fold crossoverdesign

Bayer AG0 sitesSeptember 29, 2016

Overview

No summary available.

Registry

who.int

Start Date

September 29, 2016

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

•1\. The informed consent must be signed before any study specific tests or procedures are done
•2\. Healthy male subject
•3\. Age: 18 to 45 years (inclusive) at the first screening examination/visit
•4\. Race: White
•5\. Body mass index (BMI): \=18 and \=29\.9 kg/ m²
•6\. Ability to understand and follow study\-related instructions
•7\. Confirmation of the subject’s health insurance coverage prior to the first screening examination/ visit
•8\. Male subjects with a female partner of childbearing potential must agree to use adequate contraception when sexually active. Adequate contraception is defined as of at least 2 effective methods of birth control, of which at least one is a physical barrier
•(e.g. condom or diaphragm or cervical cap with hormonal contraception, condom or diaphragm or cervical cap with an intrauterine device). This applies for the time period
•between signing of the informed consent form and 1 week after the last administration of study drug

•Medical and surgical history
•1\.Subjects with conspicuous findings in medical history and pre\-study examination in the opinion of the investigator
•2\.A history of relevant diseases of vital organs, of the central nervous system or other organs
•3\.Known renal or liver insufficiency
•4\.Subjects with diagnosed malignancy, psychiatric disorders, or thyroid disorders (evaluated by medical history, physical examination, clinical symptoms, and assessment of thyroid stimulating hormone at screening)
•5\.Medical disorder that would impair the subject’s ability to complete the study in the opinion of the investigator
•6\.Incompletely cured pre\-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
•7\.Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
•8\.Known hypersensitivity to components of the American breakfast
•9\.Known severe allergies, non\-allergic drug reactions, or multiple drug allergies