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Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 5 mg/850 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy® 5 mg/850 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany) | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 5 mg/850 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy® 5 mg/850 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany)

Open-label, Randomized, Two-period Comparative Pharmacokinetics and Bioequivalence Study of Empagliflozin + Metformin Hydrochloride 5 mg/850 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy® 5 mg/850 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany) in Healthy Volunteers Under Fed Conditions

NCT06766500•Gedeon Richter Plc.

View on ClinicalTrials.gov

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. In Russia, the brand name is Synjardy®. 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 5 mg empagliflozin and 850 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 \[prescribed course of medical treatment\], effectiveness, and tolerability.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. 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.
•2. 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;
•3. 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);
•4. 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;
•5. A volunteer must agree the following requirements:
•1. Female volunteers of childbearing potential must confirm the absence of unprotected sexual intercourse with unsterilized partner within 30 days before screening;
•2. 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;
•3. 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;
•4. 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;
+4 more criteria

Exclusion Criteria

•1. 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;
•2. Known history or presence of clinically significant disease of the gastrointestinal tract, surgical interventions on gastrointestinal tract (except appendectomy);
•3. 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;
•4. Acute or chronic infectious disease within 4 weeks before screening;
•5. History or presence of malignant disease;
•6. Presence of clinically significant hepatic or renal dysfunction as per Investigator's discretion;
•7. 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;
•8. 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.
•9. Use of medications with potent effect on hemodynamics, and liver function (barbiturates, omeprazole, cimetidine, etc.) within 30 days before screening and thereafter;
•10. Donation of blood or plasma (450 ml and more) within 2 months before screening;
+24 more criteria

Locations (1)

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

Yaroslavl, Russia

Key Dates

Start Date

January 20, 2025

Primary Completion Date

February 28, 2025

Completion Date

February 28, 2025

Last Updated

April 16, 2025

Enrollment

ACTUAL participants

Conditions

Diabetes Mellitus Type 2

Interventions

Empagliflozin + Metformin hydrochloride 5 mg/850 mg combination film-coated tablets

DRUG

Synjardy® 5 mg/850 mg film-coated tablets

DRUG

DISCOVERY of Risk Factors for Type 2 Diabetes in Youth

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Diabetes Mellitus Type 2, Childhood-Onset

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RECRUITINGNA

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Type 1 Diabetes (T1D)Type 2 Diabetes+9 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 5 mg/850 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy® 5 mg/850 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany)

Inclusion Criteria

Exclusion Criteria

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