Completed

EB-24-003Bioequivalence of EMPAGLIFLOZIN (25 mg Tablets) vs. JARDIANCE in Healthy Adults

Study Aim

This study aims to compare the bioequivalence of EMPAGLIFLOZIN (25 mg Tablets) with JARDIANCE in healthy adults, by evaluating the pharmacokinetic parameters AUC0-t and Cmax.

What is being tested

Empagliflozin (Jardiance®) Tablet Study

+ Empagliflozin Oral Treatment

Drug

Who is being recruted

From 18 to 55 Years

+30 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Services Research Study

Interventional

Study Start: November 2024

See protocol details

Summary

Principal SponsorADIUM

Last updated: March 18, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: November 29, 2024

Actual date on which the first participant was enrolled.

The study design was a randomized, open-label, two-way, crossover, single-dose, prospective, and longitudinal study, with a 7-day wash-out period before next dosing; to compare the pharmacokinetic profile (Cmax and AUC0-t) of two 25 mg empagliflozin tablet formulations in thirty-two (32) healthy Mexican adult volunteers aged 18 to 55 years.

NCT07479108

Principal SponsorADIUM

Last updated: March 18, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

32 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

15 inclusion criteria required to participate

Not blocked in the COFEPRIS research subject database

Negative qualitative pregnancy test (for women)

Clinical laboratory test results within normal limits or with clinically insignificant variations

Negative breath alcohol test

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15 exclusion criteria prevent from participating

Positive (qualitative) pregnancy test

Subjects with lactose intolerance

Subjects who have been exposed to agents known to induce or inhibit hepatic enzyme systems or who have taken potentially toxic medications within 30 days prior to the start of the study

Subjects requiring any medication during the course of the study that interferes with the quantification or pharmacokinetics of the study drug

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

Participants in this group receive Empagliflozin (Jardiance®), a diabetes medication, in the form of a 25 mg tablet. This group is used as a reference for comparison with other treatment groups in the clinical trial.

Group II

Experimental

Participants in this group receive Empagliflozin, a medication, in the form of a 25 mg tablet taken orally.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

FS Scientia Pharma

San Luis Potosí City, MexicoOpen FS Scientia Pharma in Google Maps

CompletedOne Study Center