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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 in healthy male participants
EU CTIS ID: 2022-502385-24-00
What this study is testing
To assess the bioequivalence between finerenone 2 x 20 mg tablets and 1 x 40 mg tablet
- Human Pharmacology (Phase I)- Bioequivalence Study
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, body temperature, vital signs, and ECG.
- BMI within the range 18.0 to 29.9 kg/m2 (inclusive) at the screening visit.
- Contraceptive use by men and female partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
You likely can't join if
- Known hypersensitivity to any study intervention (active substances or excipients of the preparations) to be used in the study – including e.g., non-investigational medicinal products, challenge agents, or rescue medication.
- Participant with thyroid disorders as evidenced by assessment of thyroid stimulating hormone level outside the normal reference range at the screening visit.
- Medical disorder, condition or history of such that would impair the participant’s ability to take part in or complete this study in the opinion of the investigator.
- Diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention(s) will not be normal.
- Use of systemic or topical medicines or substances which might influence the study objectives.
- Suspicion of drug or alcohol abuse.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.