Type 2 Diabetes Mellitus (T2DM)Phase 1NCT07266766
Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg
A Phase 1 study testing Empagliflozin / Metformin HCl XR Tablets and Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets) in people with Type 2 Diabetes Mellitus (T2DM), run by Humanis Saglık Anonim Sirketi at 1 site in India.
Trial summary
An Open Label, Balanced, Randomized, Single dose, Two treatment, Two sequence, Two period, two way crossover, Oral Bioequivalence Study of test product of Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet and Reference product of Synjardy XR tablets 25mg/1000mg in Healthy, adult, human Subjects Under… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Empagliflozin / Metformin HCl XR Tablets and Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 5 Aug 2025to 6 Oct 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
- No healthy volunteers
- Adult
Who may be able to join
- Subjects aged between 18 to 45 years (both inclusive).
- Subjects' weight within normal range according to normal values for Body Mass Index (between 18.5 to 30.0 kg/m2) (both inclusive) with minimum of 45 kg weight.
- Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within Predefined site Normal range.
- Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
- Subjects having clinically acceptable chest X-Ray (PA view), if taken.
- Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
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- Subjects having negative urine alcohol test / breath alcohol test.
- Non-smoker.
- Subjects willing to adhere to the protocol requirements and to provide written informed consent.
- Subject with Creatinine Clearance ˃60 ml/min.
- For male Subjects:
- Subjects willing to follow approved birth control methods (a double barrier method) for the duration of the study as judged by the investigator(s), such as (a double barrier method) condom with spermicide, Condom with diaphragm, or abstinence. Subjects willing to refrain from donating sperm during the study period - For Female Subjects: Female of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as intrauterine device (IUD), abstinence, bilateral tubal ligation or double barrier contraception, i.e., condom + diaphragm, condom + spermicidal or foam Postmenopausal for at least 1 year, or if less than 1 year, then following acceptable contraceptive measures as mentioned above
- Subjects having negative urine pregnancy test at screening and negative serum b-hCG pregnancy test on admission day of period 01 (only for female subjects).
Who cannot join
- Hypersensitivity to Empagliflozin and Metformin or related class of drugs or any of its excipients or heparin.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, urogenital or psychiatric disease or disorder.
- Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 30 days prior to admission in period 01.
- Presence of alcoholism or drug abuse.
- History or presence of asthma, urticaria or other significant allergic reactions.
- History or presence of significant gastric and/or duodenal ulceration.
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- History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- History or presence of cancer or basal or squamous cell carcinoma.
- Difficulty with donating blood.
- Difficulty in swallowing solids dosage form like tablets or capsules.
- Use of any prescribed medication or OTC medication including vaccines, vitamins and herbal remedies during last 30 days prior to admission in period 01.
- Major illness within past 3 months.
- Volunteer who have donated blood (1 unit) or participation in a drug research study within past 90 days prior to the first dose of the study drug.
- Consumption of xanthine-containing products, tobacco containing products or alcohol or any alcohol containing products within 48.00 hours prior to admission in period 01.
- Consumption of grapefruit or grapefruit juice containing products within 72.00 hours prior to admission of period 01.
- Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
- History or presence of significant easy bruising or bleeding.
- History or presence of significant recent trauma.
- Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
- History of any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).
- History of Diabetic pre-coma.
- History of acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
- History of disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: decompensated heart failure, respiratory failure, recent myocardial infarction, shock.
- History of Hepatic impairment or acute alcohol intoxication.
- Female subjects who are currently breast feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Balanced, Randomized, Single Dose, Two Treatment, Two Sequence, Two Period, Two Way Crossover, Oral Bioequivalence Study of Test Product of Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet and Reference Product of Synjardy XR Tablets 25mg/1000mg in Healthy, Adult, Human Subjects Under Fed Condition.
An Open Label, Balanced, Randomized, Single dose, Two treatment, Two sequence, Two period, two way crossover, Oral Bioequivalence Study of test product of Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet and Reference product of Synjardy XR tablets 25mg/1000mg in Healthy, adult, human Subjects Under fed Condition.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Empagliflozin / Metformin HCl XR Tablets, Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin / Metformin HCl XR TabletsDrug
One Empagliflozin / Metformin HCl XR 25 mg/ 1000 mg Tablets
Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets)Drug
One Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets) 25 mg/1000 mg
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin / Metformin HCl XR Tablets | Experimental | Empagliflozin / Metformin HCl XR 25 mg/ 1000 mg Tablets Receives: Drug: Empagliflozin / Metformin HCl XR Tablets; Drug: Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets) |
| Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets) | Active comparator | Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets) 25 mg/1000 mg Receives: Drug: Empagliflozin / Metformin HCl XR Tablets; Drug: Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets) |
What is being measured
The primary outcome is the main question the study is designed to answer.
For Empagliflozin & Metformin; Maximum concentration obtained (Cmax)
two-sides 90% CI for the test to reference ratio of the population means is within 80.00-125.00% for each of the Ln-transformed data Cmax
Measured: 72 hours
For Empagliflozin & Metformin; AUC from time 0 to last collection time (AUC0 - t)
two-sides 90% CI for the test to reference ratio of the population means is within 80.00-125.00% for each of the Ln-transformed data AUC
Measured: 72 hours
Secondary outcomes (2)
For Empagliflozin & Metformin; Time to reach maximum concentration Cmax (Tmax)
Descriptive Statistics
Measured: 72 hours
For Empagliflozin & Metformin; AUC0-24
Descriptive Statistics
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start5 Aug 2025
- Primary completion24 Sep 2025
- Study completion6 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanis Saglık Anonim Sirketi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266766
- Sponsor's protocol ID
- 25-VIN-0321
- Status last verified
- Oct 2025
- First submitted
- 28 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Balanced, Randomized, Single Dose, Two Treatment, Two Sequence, Two Period, Two Way Crossover, Oral Bioequivalence Study of Test Product of Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet and Reference Product of Synjardy XR Tablets 25mg/1000mg in Healthy, Adult, Human Subjects Under Fed Condition.
- ClinicalTrials.gov ID
- NCT07266766
- Acronym / sponsor ID
- 25-VIN-0321
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Humanis Saglık Anonim SirketiIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 24 Sep 2025 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 5 Dec 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.
An Open Label, Balanced, Randomized, Single dose, Two treatment, Two sequence, Two period, two way crossover, Oral Bioequivalence Study of test product of Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet and Reference product of Synjardy XR tablets 25mg/1000mg in Healthy, adult, human Subjects Under fed Condition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin / Metformin HCl XR Tablets | Experimental | Drug: Empagliflozin / Metformin HCl XR Tablets, Drug: Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets)Empagliflozin / Metformin HCl XR 25 mg/ 1000 mg Tablets |
| Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets) | Active comparator | Drug: Empagliflozin / Metformin HCl XR Tablets, Drug: Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets)Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets) 25 mg/1000 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Subjects aged between 18 to 45 years (both inclusive).
- Subjects' weight within normal range according to normal values for Body Mass Index (between 18.5 to 30.0 kg/m2) (both inclusive) with minimum of 45 kg weight.
- Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within Predefined site Normal range.
- Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
- Subjects having clinically acceptable chest X-Ray (PA view), if taken.
Key exclusion criteria (25 listed)
- Hypersensitivity to Empagliflozin and Metformin or related class of drugs or any of its excipients or heparin.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, urogenital or psychiatric disease or disorder.
- Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 30 days prior to admission in period 01.
- Presence of alcoholism or drug abuse.
- History or presence of asthma, urticaria or other significant allergic reactions.
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 HCl XR TabletsOne Empagliflozin / Metformin HCl XR 25 mg/ 1000 mg Tablets | Drug | Empagliflozin / Metformin HCl XR Tablets, Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets) |
| Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets)One Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets) 25 mg/1000 mg | Drug | Empagliflozin / Metformin HCl XR Tablets, Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets) |
Primary outcome
For Empagliflozin & Metformin; Maximum concentration obtained (Cmax)
Time frame: 72 hours
two-sides 90% CI for the test to reference ratio of the population means is within 80.00-125.00% for each of the Ln-transformed data Cmax
For Empagliflozin & Metformin; AUC from time 0 to last collection time (AUC0 - t)
Time frame: 72 hours
two-sides 90% CI for the test to reference ratio of the population means is within 80.00-125.00% for each of the Ln-transformed data AUC
2 secondary outcomes
For Empagliflozin & Metformin; Time to reach maximum concentration Cmax (Tmax)
Time frame: 72 hours
For Empagliflozin & Metformin; AUC0-24
Time frame: 72 hours
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 5 Dec 2025.
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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?
A Phase 1 study testing Empagliflozin / Metformin HCl XR Tablets and Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets) in people with Type 2 Diabetes Mellitus (T2DM), run by Humanis Saglık Anonim Sirketi at 1 site in India.
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 13 inclusion and 25 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 5 Dec 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 India. 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?
For Empagliflozin & Metformin; Maximum concentration obtained (Cmax) (time frame: 72 hours). 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?
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 5 Dec 2025.