CLINICAL STUDY TO DETERMINE BIOEQUIVALENCE BETWEEN TWO ORAL MEDICATIONS OF EMPAGLIFLOZIN/METFORMIN IN 12.5 mg / 850 mg TABLETS UNDER FED CONDITIONS. (ACL24-PC019)

CLINICAL STUDY TO DETERMINE BIOEQUIVALENCE BETWEEN TWO ORAL MEDICATIONS OF EMPAGLIFLOZIN/METFORMIN IN 12.5 mg / 850 mg TABLETS IN HEALTHY SUBJECTS UNDER FED CONDITIONS.

Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study

Study Overview

• Status: Completed
• Conditions: Bioequivalence Study in Healthy Subjects
• Intervention / Treatment: Drug: Synjardy 12.5/850 mg tablet (Reference); Drug: Empagliflozin/metformin 12.5/850 mg tablet (test)

Detailed Description

The study design was a randomized, open-label, two-way, crossover, single-dose, prospective, and longitudinal study, with a 14-day wash-out period before next dosing; to compare the pharmacokinetic profile (Cmax and AUC0-t) of two 12.5/ 850 mg empagliflozin/metformin FDC tablet in forty-two (42) healthy Mexican adult volunteers aged 18 to 55 years.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City
    • Mexico City, Mexico City, Mexico, 07870
      • Axis Clinicals Latina, S.A. de C.V.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age between 18 and 55 years.
2. Clinically healthy according to the updated medical history prior to the start of the study.
3. Not blocked in the COFEPRIS research subject database.
4. Body mass index between 18 and 27 kg/m².
5. Normal vital signs: Heart rate between 60 and 99 beats per minute, respiratory rate between 12 and 20 breaths per minute, systolic blood pressure between 90-130 mmHg, diastolic blood pressure between 60-89 mmHg, and temperature between 36.0 and 37.4°C.
6. Electrocardiogram (ECG) without any signs of pathology.
7. Clinical laboratory test results within normal limits or with clinically insignificant variations.
8. Negative biosafety tests for the presence of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and varicella-zoster virus (VDRL).
9. Negative drug screening tests for amphetamines, benzodiazepines, cocaine, methamphetamines, morphine, and tetrahydrocannabinol (THC).
10. Negative qualitative pregnancy test (for women).
11. Negative breath alcohol test.
12. Research subjects with no history of alcohol abuse or dependence, psychoactive substance abuse, or chronic medication use.
13. Subjects with a signed informed consent form and a signed non-pregnancy commitment letter.
14. Women who are not pregnant or breastfeeding.
15. Women using at least one method of family planning deemed safe by the principal investigator.

Exclusion Criteria:

1. Subjects with a history of hypersensitivity to the study drug.
2. Subjects with lactose intolerance.
3. 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.
4. Subjects requiring any medication during the course of the study that interferes with the quantification or pharmacokinetics of the study drug.
5. 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.
6. Subjects who, prior to receiving the study drug, have taken medications such as those described in section 3.11 "Drug Interactions."
7. Subjects who have been hospitalized for any reason within sixty days prior to the start of the study or who have been seriously ill within thirty days prior to the start of the study.
8. Subjects who have received an investigational drug within ninety days prior to the start of the study.
9. Subjects who have donated or lost 450 mL or more of blood within sixty days prior to the start of the study.
10. Research subjects with a history of alcohol or psychoactive substance abuse or dependence, or chronic medication use.
11. Subjects who have consumed beverages or foods containing xanthines (coffee, tea, cocoa, chocolate, yerba mate, cola, etc.) or have consumed charcoal-grilled foods within 12 hours prior to administration of the medication dose.
12. Subjects who have consumed grapefruit, cranberry, or pomegranate juice within 12 hours prior to the study.
13. Subjects who have smoked at least 12 hours before the start of the study.
14. Subjects who have ingested alcoholic beverages 48 hours prior to administration of the dose.
15. Positive (qualitative) pregnancy test.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Reference; Synjardy 12.5/850 mg tablet, Reference	Drug: Synjardy 12.5/850 mg tablet (Reference); Reference
Experimental: Test; Empagliflozin/metformin 12.5/850 mg tablet	Drug: Empagliflozin/metformin 12.5/850 mg tablet (test); Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bioequivalence based on the pharmacokinetic parameter: AUC0-t	Bioequivalence based on the pharmacokinetic parameter: AUC0-t	Through 48 hours Post Dose
Bioequivalence based on the pharmacokinetic parameter: Cmax	Bioequivalence based on the pharmacokinetic parameter: Cmax	Through 48 Hours Post Dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize the pharmacokinetic parameter: AUC0-inf	Characterize the pharmacokinetic parameter: AUC0-inf	Through 48 Hours Post Dose
Characterize the pharmacokinetic parameter: time to maximum concentration (tmax)	Characterize the pharmacokinetic parameter: time to maximum concentration (tmax)	Through 48 Hours Post Dose
Characterize the pharmacokinetic parameter: half-life (t1/2)	Characterize the pharmacokinetic parameter: half-life (t1/2)	Through 48 Hours Post Dose
Establish the frequency, severity, and seriousness of adverse events that occurred during the study.	Establish the frequency, severity, and seriousness of adverse events that occurred during the study.	Until the final visit (14 days after the last dose)
Characterize the pharmacokinetic parameter: elimination constant (Ke)	Characterize the pharmacokinetic parameter: elimination constant (Ke)	Through 48 Hours Post Dose

Collaborators and Investigators

• Sponsor: ADIUM

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2025
• Primary Completion (Actual): April 8, 2025
• Study Completion (Actual): April 8, 2025

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: bioequivalence; metformin; empagliflozin
• Additional Relevant MeSH Terms: Organic Chemicals; Pharmaceutical Preparations; Dosage Forms; Biguanides; Guanidines; Amidines; Metformin; empagliflozin; Tablets
• Other Study ID Numbers: ACL24-PC019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon request, the clinical research site will provide this data with prior authorization from the sponsor, without disclosing personal information. All information will be uniquely identified by the research subject's initials and/or their assigned randomization number, thus guaranteeing their privacy.
• IPD Sharing Time Frame: Upon request
• IPD Sharing Access Criteria: Upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No