Bioequivalence test of two Vicadrostat/Empagliflozin formulations in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial in healthy men and women compares two formulations of Vicadrostat combined with Empagliflozin to see if they achieve similar blood levels after oral dosing. Participants will undergo screening, receive the formulations, and have blood and vital signs monitored to assess pharmacokinetic similarity. The study aims to establish bioequivalence between the two formulations under controlled conditions. Only healthy adults meeting specific criteria will participate, and informed consent is required. The trial is sponsored by Boehringer Ingelheim and conducted at a single center in Biberach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Healthy male or female trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure, Pulse rate), 12-lead Electrocardiogram, and clinical laboratory tests
2. Age of 18 to 55 years (inclusive)
3. Body mass index of 18.5 to 29.9 kg / m\^2 (inclusive)
4. Signed and dated written informed consent in accordance with International Council for Harmonisation - Good Clinical Practice and local legislation prior to admission to the trial
5. Further inclusion criteria apply.

Exclusion Criteria:

1. Any finding in the medical examination (including Blood pressure, Pulse rate or Electrocardiogram) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Further exclusion criteria apply.

Where it's running

• Humanpharmakologisches Zentrum Biberach
  Biberach, Germany Recruiting

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 1-800-243-0127

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.