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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-27

Study Completion Date

2025-09-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment sequence A

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

Group Type EXPERIMENTAL

Empagliflozin

Intervention Type DRUG

Empagliflozin

Treatment sequence B

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

Group Type EXPERIMENTAL

Empagliflozin

Intervention Type DRUG

Empagliflozin

Interventions

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Empagliflozin

Intervention Type DRUG

Eligibility Criteria

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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)

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes