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

Boehringer Ingelheim

Status and phase: Begins enrollment this month; Phase 1

Conditions: Healthy

Treatments: Drug: Empagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06962826

2025-520813-29-00 (EU Trial (CTIS) Number)

U1111-1313-4642 (Registry Identifier)

1245-0358

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Treatment sequence A

Experimental group

Description:

R - reference treatment: Empagliflozin tablet, administered to subjects in fasting state with water T - test treatment: Empagliflozin dispersed in water and mixed with food, administered to subjects in fasting state with water

Treatment:

Drug: Empagliflozin

Treatment sequence B

Experimental group

Description:

T - test treatment: Empagliflozin dispersed in water and mixed with food, administered to subjects in fasting state with water R - reference treatment: Empagliflozin tablet, administered to subjects in fasting state with water

Treatment:

Drug: Empagliflozin