Diabetes Mellitus Type 2Phase 1NCT06823856

Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 12.5 mg/1000 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy 12.5 mg/1000 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany)

A Phase 1 study testing Empagliflozin + Metformin hydrochloride 12.5 mg/1000 mg combination film-coated tablets and Synjardy 12.5 mg/1000 mg film-coated tablets in people with Diabetes Mellitus Type 2, run by Gedeon Richter Plc. at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Empagliflozin and metformin hydrochloride are two separate drugs. The combination of these two drugs in one tablet are used for the treatment of type 2 diabetes, along with diet and exercise, and can be used with other drugs, if required. It is approved in Russia and also various other countries. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus Type 2
What is being tested?: Empagliflozin + Metformin hydrochloride 12.5 mg/1000 mg combination film-coated tablets and Synjardy 12.5 mg/1000 mg film-coated tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteRussia
Study dates: 11 May 2025to 21 May 2025
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Presence of the written informed consent of the volunteer to participate in the study in accordance with the current legislation, volunteer's agreement to observe all study restrictions and consent to come back to the center for providing of all study procedures.
Verified as "healthy" by the Investigator based on the results of the standard clinical and laboratory tests and instrumental investigations, results of physical examination and medical history data;
Male and female volunteers of Caucasian race, aged 18 to 45 years (inclusive) at screening.
Female volunteers can be with childbearing or non-childbearing potential. Female volunteers of non-childbearing potential are defined as: females with documented menopause (defined as the absence of menstruation for at least 12 consecutive months without an alternative medical cause with follicle-stimulating hormone (FSH) level at screening ≥25 mIU/mL) or females with documented surgical sterilization (hysterectomy, bilateral ovary- or tubectomy, uterine tubes ligation);
Body mass index (BMI) (by Quetelet) between 18.5 and 30 kg/m2 (inclusive). Body weight must be more than 45 kg and less than 100 kg;
A volunteer must agree the following requirements:

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Female volunteers of childbearing potential must confirm the absence of unprotected sexual intercourse with unsterilized partner within 30 days before screening;
Female volunteers must agree to sexual abstinence or to use consistently and correctly one of the adequate contraceptive methods listed below during their participation in this study and for 30 days after the last dose of the IMP;
Male volunteers must agree to sexual abstinence or together with their female partners of childbearing potential must use consistently and correctly one of the adequate contraceptive methods listed below during their participation in this study and for 30 days after the last dose of the IMP;
Male volunteers must agree to refrain from donating sperm during their participation in this study and for 30 days after the last dose of the IMP;
Note: Adequate contraceptive methods include:
Non-hormonal intrauterine device (IUD);
Barrier method in combination with spermicidal drug or diaphragm (diaphragm with spermicide, cervical cap with spermicide, condom with spermicide).
A volunteer has suitable veins for cannulation.

Who cannot join

Known history or presence of clinically significant neurologic, hematologic, endocrine (including diabetes mellitus 1 and 2 type), oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results;
Known history or presence of clinically significant disease of the gastrointestinal tract, surgical interventions on gastrointestinal tract (except appendectomy);
Burdened allergological anamnesis, including known history of anaphylactic reaction/anaphylactic shock, known history or presence of hypersensitivity or idiosyncratic reaction to empagliflozin or metformin or excipients of the test/reference product, or any other drug substances with similar activity;
Acute or chronic infectious disease within 4 weeks before screening;
History or presence of malignant disease;
Presence of clinically significant hepatic or renal dysfunction as per Investigator's discretion;

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Estimated creatinine clearance of ≤60 mL/min based on the Cockcroft-Gault equation, or serum creatinine level higher than the upper limit of normal range of the local laboratory;
Use of medication (prescribed, over-the-counter medications, and natural health products [including herbal remedies, phytohormones, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports]) within 14 days prior to screening and thereafter. It is allowed to use medical products without systemic absorption.
Use of medications with potent effect on hemodynamics, and liver function (barbiturates, omeprazole, cimetidine, etc.) within 30 days before screening and thereafter;
Donation of blood or plasma (450 ml and more) within 2 months before screening;
Blood or plasma transfusion within 1 year before screening;
Results of standard laboratory investigations outside the normal range of the local laboratory, which are considered clinically significant by the Investigator;
ECG abnormalities, including clinically significant arrhythmia, or suspected arrhythmia as judged by the Investigator;
Vital sign abnormalities at the screening (systolic blood pressure [BP] < 100 or > 130 mmHg, diastolic BP < 60 or > 90 mmHg, or heart rate [HR] < 60 or > 90 bpm);
Positive test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or syphilis. It is allowed to use results of the HIV test, hepatitis viruses B and C tests and syphilis analysis, which were performed within 3 months before screening visit;
Positive test for SARS-CoV-2 using express immunochromatographic test system for qualitative detection of SARS-CoV-2 antigen in smears from the nasopharynx or oropharynx;
Positive urine cotinine test at screening or at Day 0, or smoking cigarettes or tobacco or consuming any nicotine products (patches, chewing gum etc.) during 6 months prior to screening;
Positive alcohol breath test at screening or at Day 0, or history of significant alcohol abuse within one year prior to screening, regular use of alcohol within 6 months prior to screening (more than 10 units of alcohol per week [1 unit = 200 mL of dry wine, 400 mL of beer, or 50 mL of 40% alcohol]), or consumption of alcohol within 72 hours prior to screening/72 hours prior to dosing;
Positive urine screening for narcotic, psychotropic, and potent substances at screening or at Day 0, or history of significant drug abuse or use of illegal drugs (such as marijuana, cocaine, phencyclidine, crack, opioid derivatives including heroin, and amphetamine derivatives).
Positive pregnancy test at screening or at Day 0 (the test is performed to all female volunteers);
Female volunteers who are pregnant or lactating, who wish to get pregnant; female volunteers of childbearing potential with presence of unprotected sexual intercourse with unsterilized partner within 30 days before screening; male subjects who wish to conceive during participation in the study;
Female volunteers who have used hormonal contraceptives (implanted, injected, intravaginal, or intrauterine hormonal contraceptives within 6 months prior to screening; oral or transdermal hormonal contraceptives within 21 days prior to screening) or wish to use them during participation in the study;
Consumption of food containing poppy seeds within 72 hours prior screening / 72 hours prior to hospitalization in the first period;
Consumption of food or beverages containing xanthine derivatives or xanthine-related compounds (e.g. tea, coffee, cola, chocolates) or energy drinks from 72 hours prior to first dosing;
Consumption of food or beverages containing grapefruit, starfruit, pomegranate, pineapple, or pomelo from 14 days prior to the first dosing;
Dehydration due to diarrhea, vomiting or other causes during the last 24 hours before dosing;
Participation in a clinical trial that involved administration of an investigational medicinal product within 30 days prior to drug administration or within 5 times the half-life of the previous IMP used, whichever is longer, or recent participation in a clinical investigation that, in the opinion of the Investigator, would jeopardize subject safety or the integrity of the study results;
Difficulties with staying fasting or consuming standardized high-calorie breakfast/other meal provided by the site;
Planned or scheduled surgery within 7 days prior or 7 days after study drugs administration;
Difficulties with swallowing tablets or capsules whole;
Following a special diet within 30 days prior to the first drug administration (e.g., liquid, protein, raw food diet, vegetarian, vegan);
Mental, physical or other reasons that do not allow the volunteer to adequately assess his/her behaviour and correctly fulfil the conditions of the study protocol;
Other diseases/conditions that, in the opinion of the Investigator, may affect the pharmacokinetics of the study drugs or increase the risk for the health of the volunteer;
Any reason which, in the opinion of the Investigator, would prevent the volunteer from participating in the study.

Trial locations and contacts

1 site in 1 country.

Russia1 site

State Budgetary Institution of Healthcare of Yaroslavl region "Yaroslavl Regional Clinical Narcological Hospital
Yaroslavl, 150054

Other trials in Russia

About this study

Official title: Open-label, Randomized, Two-period Comparative Pharmacokinetics and Bioequivalence Study of Empagliflozin + Metformin Hydrochloride 12.5 mg/1000 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy 12.5 mg/1000 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany) in Healthy Volunteers Under Fed Conditions

The purpose of this research study is to measure the amount of the two drugs in the blood after taking two different formulations of the combination tablet. One formulation, also called Synjardy®, is an approved product in Russia marketed by Boehringer Ingelheim International GmbH, Germany. The other formulation is an investigational product that is not approved. The data from this study will be used to compare the two products.

Subjects participating in this study will take 12.5 mg empagliflozin and 1000 mg metformin hydrochloride (1 combination film-coated tablet) of one formulation in each period. The maximum recommended daily dose is 25 mg of empagliflozin and 2,000 mg of metformin hydrochloride which is based on the subject's current regimen, effectiveness, and tolerability.

Conditions: Diabetes Mellitus Type 2
Being tested: Empagliflozin + Metformin hydrochloride 12.5 mg/1000 mg combination film-coated tablets, Synjardy 12.5 mg/1000 mg film-coated tablets
Keywords: Diabetes, Diabetes Mellitus Type 2, Empagliflozin, Metformin
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Empagliflozin + Metformin hydrochloride 12.5 mg/1000 mg combination film-coated tabletsDrug
1 tablet of Empagliflozin + Metformin hydrochloride 12.5 mg/1000 mg combination film-coated table
Synjardy 12.5 mg/1000 mg film-coated tabletsDrug
1 tablet of Empagliflozin+Metformin 12.5 mg/1000 mg filmcoated tablets

Study groups in NCT06823856
Study group	Role	What they receive
Empagliflozin + Metformin hydrochloride combination film-coated tablets	Experimental	Combination tablet of Empagliflozin + Metformin hydrochloride 12.5 mg/1000 mg of Gedeon Richter Plc., Hungary Receives: Drug: Empagliflozin + Metformin hydrochloride 12.5 mg/1000 mg combination film-coated tablets
Synjardy film-coated tablets	Active comparator	Synjardy 12.5 mg/1000 mg of Boehringer Ingelheim International GmbH, Germany Receives: Drug: Synjardy 12.5 mg/1000 mg film-coated tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Bioequivalence of Empagliflozin + Metformin hydrochloride film-coated tablets and Synjardy® film-coated tablets via measuring the AUC from time 0 to last collection time t (AUC0-t)
The primary purpose of the study is to assess the bioequivalence of Empagliflozin + Metformin hydrochloride 12.5 mg/1000 mg film-coated tablets (Gedeon Richter Plc., Hungary) and Synjardy 12.5 mg/1000 mg film-coated tablets (Boehringer Ingelheim International GmbH, Germany) in healthy, adult volunteers under fed conditions. The measurement will be based on two-sided 90% CI for the test to reference ratio of the population means is within 80.00% to 125.00% for each of the Ln-transformed data of AUC.
Measured: From enrollment to the end of treatment at about 7 weeks
Bioequivalence of Empagliflozin + Metformin hydrochloride film-coated tablets and Synjardy® film-coated tablets via measuring the maximum concentration in plasma (Cmax)
The primary purpose of the study is to assess the bioequivalence of Empagliflozin + Metformin hydrochloride 12.5 mg/1000 mg film-coated tablets (Gedeon Richter Plc., Hungary) and Synjardy 12.5 mg/1000 mg film-coated tablets (Boehringer Ingelheim International GmbH, Germany) in healthy, adult volunteers under fed conditions. The measurement will be based on two-sided 90% CI for the test to reference ratio of the population means is within 80.00% to 125.00% for each of the Ln-transformed data of Cmax.
Measured: From enrollment to the end of treatment at about 7 weeks

Secondary outcomes (1)

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The secondary purpose is to assess the safety and tolerability of the study products from the signing of the informed consent form (ICF) until the end of the study. There will be no formal statistical evaluation of safety or tolerability. The safety results will be provided as listings and summary tables for each treatment group. Adverse event data listing will include AEs onset and resolution date/time, duration, time from dosing, severity, relationship to the IMP and/or the additional drug product, outcome, and the action taken to the IMP and/or additional drug product and to treat the AE.
Measured: From enrollment to the end of treatment at about 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 May 202521 May 2025

First posted12 Feb 2025
Study start11 May 2025
Primary completion21 May 2025
Study completion21 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06823856
Sponsor's protocol ID: EAEU-GCO-MET/EMP-03-2023
Status last verified: Feb 2025
First submitted: 7 Feb 2025
Last updated: 23 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-label, Randomized, Two-period Comparative Pharmacokinetics and Bioequivalence Study of Empagliflozin + Metformin Hydrochloride 12.5 mg/1000 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy 12.5 mg/1000 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany) in Healthy Volunteers Under Fed Conditions
ClinicalTrials.gov ID: NCT06823856
Acronym / sponsor ID: EAEU-GCO-MET/EMP-03-2023
Conditions: Diabetes Mellitus Type 2
Keywords: Diabetes, Diabetes Mellitus Type 2, Empagliflozin, Metformin
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Gedeon Richter Plc.Industry (pharma, biotech, devices)
Study start: 11 May 2025 (actual)
Primary completion: 21 May 2025 (actual)
Study completion: 21 May 2025 (actual)
First posted: 12 Feb 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Empagliflozin + Metformin hydrochloride combination film-coated tablets	Experimental	Drug: Empagliflozin + Metformin hydrochloride 12.5 mg/1000 mg combination film-coated tabletsCombination tablet of Empagliflozin + Metformin hydrochloride 12.5 mg/1000 mg of Gedeon Richter Plc., Hungary
Synjardy film-coated tablets	Active comparator	Drug: Synjardy 12.5 mg/1000 mg film-coated tabletsSynjardy 12.5 mg/1000 mg of Boehringer Ingelheim International GmbH, Germany

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (14 listed)

Presence of the written informed consent of the volunteer to participate in the study in accordance with the current legislation, volunteer's agreement to observe all study restrictions and consent to come back to the center for providing of all study procedures.
Verified as "healthy" by the Investigator based on the results of the standard clinical and laboratory tests and instrumental investigations, results of physical examination and medical history data;
Male and female volunteers of Caucasian race, aged 18 to 45 years (inclusive) at screening.
Female volunteers can be with childbearing or non-childbearing potential. Female volunteers of non-childbearing potential are defined as: females with documented menopause (defined as the absence of menstruation for at least 12 consecutive months without an alternative medical cause with follicle-stimulating hormone (FSH) level at screening ≥25 mIU/mL) or females with documented surgical sterilization (hysterectomy, bilateral ovary- or tubectomy, uterine tubes ligation);
Body mass index (BMI) (by Quetelet) between 18.5 and 30 kg/m2 (inclusive). Body weight must be more than 45 kg and less than 100 kg;

Key exclusion criteria (34 listed)

Known history or presence of clinically significant neurologic, hematologic, endocrine (including diabetes mellitus 1 and 2 type), oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results;
Known history or presence of clinically significant disease of the gastrointestinal tract, surgical interventions on gastrointestinal tract (except appendectomy);
Burdened allergological anamnesis, including known history of anaphylactic reaction/anaphylactic shock, known history or presence of hypersensitivity or idiosyncratic reaction to empagliflozin or metformin or excipients of the test/reference product, or any other drug substances with similar activity;
Acute or chronic infectious disease within 4 weeks before screening;
History or presence of malignant disease;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Empagliflozin + Metformin hydrochloride 12.5 mg/1000 mg combination film-coated tablets1 tablet of Empagliflozin + Metformin hydrochloride 12.5 mg/1000 mg combination film-coated table	Drug	Empagliflozin + Metformin hydrochloride combination film-coated tablets
Synjardy 12.5 mg/1000 mg film-coated tablets1 tablet of Empagliflozin+Metformin 12.5 mg/1000 mg filmcoated tablets	Drug	Synjardy film-coated tablets

Primary outcome

Bioequivalence of Empagliflozin + Metformin hydrochloride film-coated tablets and Synjardy® film-coated tablets via measuring the AUC from time 0 to last collection time t (AUC0-t)
Time frame: From enrollment to the end of treatment at about 7 weeks
The primary purpose of the study is to assess the bioequivalence of Empagliflozin + Metformin hydrochloride 12.5 mg/1000 mg film-coated tablets (Gedeon Richter Plc., Hungary) and Synjardy 12.5 mg/1000 mg film-coated tablets (Boehringer Ingelheim International GmbH, Germany) in healthy, adult volunteers under fed conditions. The measurement will be based on two-sided 90% CI for the test to reference ratio of the population means is within 80.00% to 125.00% for each of the Ln-transformed data of AUC.
Bioequivalence of Empagliflozin + Metformin hydrochloride film-coated tablets and Synjardy® film-coated tablets via measuring the maximum concentration in plasma (Cmax)
Time frame: From enrollment to the end of treatment at about 7 weeks
The primary purpose of the study is to assess the bioequivalence of Empagliflozin + Metformin hydrochloride 12.5 mg/1000 mg film-coated tablets (Gedeon Richter Plc., Hungary) and Synjardy 12.5 mg/1000 mg film-coated tablets (Boehringer Ingelheim International GmbH, Germany) in healthy, adult volunteers under fed conditions. The measurement will be based on two-sided 90% CI for the test to reference ratio of the population means is within 80.00% to 125.00% for each of the Ln-transformed data of Cmax.

1 secondary outcome

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From enrollment to the end of treatment at about 7 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
Individual participant dataSharing planned: No

Related trials for Diabetes Mellitus Type 2

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bioequivalence of Empagliflozin + Metformin hydrochloride film-coated tablets and Synjardy® film-coated tablets via measuring the AUC from time 0 to last collection time t (AUC0-t) (time frame: From enrollment to the end of treatment at about 7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06823856.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.