A Study in Healthy People to Test How Empagliflozin is Taken up in the Body When Taken as a Whole Tablet or Dissolved in Water and Mixed With Food

Launched by BOEHRINGER INGELHEIM · Apr 30, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to study how a medication called empagliflozin is absorbed by the body. Researchers want to find out if taking empagliflozin as a whole tablet works the same way as when it is dissolved in water and mixed with food. The trial will help us understand the best way to take this medication, which could be important for future treatments.

To participate in this study, you need to be a healthy adult between the ages of 18 and 55, with a body mass index (BMI) between 18.5 and 29.9. Before joining, you will undergo a thorough health check, including a physical exam and some lab tests, to ensure you meet the health requirements. If you qualify and choose to participate, you can expect to take the medication under close supervision to monitor how your body reacts. It's important to know that this trial is not yet recruiting participants, but it will provide valuable information on how this medication can be taken effectively.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests.
• • Age of 18 to 55 years (inclusive)
• • Body mass index (BMI) of 18.5 to 29.9 kg/m² (inclusive)
• • Signed and dated written informed consent in accordance with International Council for Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial Further inclusion criteria apply.
• Exclusion criteria:
• • Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
• • 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
• • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• • Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.