Status:
COMPLETED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This trial is conducted to test how empagliflozin is taken up in the body when taken as a whole tablet or dissolved in water and mixed with food.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2025
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06962826
Start Date
May 27 2025
End Date
September 12 2025
Last Update
September 18 2025
Active Locations (1)
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1
Humanpharmakologisches Zentrum Biberach
Biberach, Germany, 88397