Completed

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

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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®)

+ Empagliflozin (oral)

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 19, 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.

This study focuses on comparing two versions of a diabetes medication called Empagliflozin, specifically the 25 mg tablets. One version is made by Asofarma de México S.A. de C.V., and the other is JARDIANCE® from Boehringer Ingelheim Pharmaceuticals Inc. The study involves healthy Mexican adults aged 18 to 55 years. The main goal is to see if these two versions of the medication work equally well in the body. This research is important as it helps ensure that different versions of the same medicine provide the same benefits, contributing to improved healthcare services. The study is designed in a way that each participant receives both versions of the medication at different times, with a 7-day break in between. This is a single-dose study, meaning participants take only one tablet of each version during their respective times. The study measures how the body absorbs and uses the medication, looking at two specific parameters: Cmax (the maximum concentration of the drug in the blood) and AUC0-t (the total exposure to the drug). These measurements help determine if the two versions of Empagliflozin are equivalent in terms of how they work in the body.

Official TitleBioequivalence Study of EMPAGLIFLOZIN (25 mg Tablets) From Asofarma de México S.A. de C.V. vs. JARDIANCE® (25 mg Tablets) From Boehringer Ingelheim Pharmaceuticals Inc., in Healthy Research Subjects, Under Fasting Conditions
NCT07479108
Principal SponsorADIUM
Last updated: March 19, 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
Age between 18 and 55 years
Clinically healthy according to the updated medical history prior to the start of the study
Not blocked in the COFEPRIS research subject database
Body mass index between 18 and 27 kg/m^2
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15 exclusion criteria prevent from participating
Subjects with a history of hypersensitivity to the study drug
Subjects with lactose intolerance
Subjects with a history of cardiovascular, renal, hepatic, metabolic, gastrointestinal, neurological, endocrine, hematopoietic (any type of anemia), mental illness, or other organic abnormalities that could affect the pharmacokinetic study of the study product
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

Suspended

FS Scientia Pharma

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