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

Sponsor
Boehringer Ingelheim
Study ID
NCT06962826
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
May 27, 2025
Status verified
Sep 2025
Primary completion
Jun 26, 2025
Completion
Sep 12, 2025

Study Design

Enrollment
14 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Experimental: 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

Primary Outcome Measure

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) [ Time Frame: up to 3 days ]

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