Type 2 Diabetes Mellitus (T2DM)Phase 1NCT07694115
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 Extended-Release Tablet and Synjardy XR 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, randomized, two-period, two treatment, two-sequence, crossover, balanced, single dose oral bioequivalence study to compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet versus Synjardy XR tablets 25mg/1000mg in healthy subject in fasting condition. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Empagliflozin / Metformin Extended-Release Tablet and Synjardy XR 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
- 7 May 2026to 1 Jul 2026
- 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
- Participants aged between 18 to 45 years (both inclusive).
- Participants' 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.
- Participants with normal health as determined by personal medical history, clinical examination and laboratory examinations within Predefined site Normal range [Annexure III].
- Participants having clinically acceptable 12-lead electrocardiogram (ECG).
- Participants having clinically acceptable chest X-Ray (PA view), if taken.
- Participants having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
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- Participants having negative urine alcohol test / breath alcohol test.
- Non-smoker.
- Participants willing to adhere to the protocol requirements and to provide written informed consent.
- Participant with Creatinine Clearance ˃60 ml/min.
- For male Participants: Participants 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. Participants willing to refrain from donating sperm during the study period
- For Female Participants: 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
- Participants having negative urine pregnancy test at screening and negative serum beta-hCG pregnancy test on admission day of period 01 (only for female participants).
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.
- Participant 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.
- Participants 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 participants 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 to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg in Fasting Condition.
An open label, randomized, two-period, two treatment, two-sequence, crossover, balanced, single dose oral bioequivalence study to compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet versus Synjardy XR tablets 25mg/1000mg in healthy subject in fasting condition.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Empagliflozin / Metformin Extended-Release Tablet, Synjardy XR 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 Extended-Release TabletDrug
1 extended Release tablet of Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet
Synjardy XR tabletsDrug
1 extended Release tablet of Synjardy XR tablets 25mg/1000mg
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin / Metformin Extended-Release Tablet | Experimental | Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Receives: Drug: Empagliflozin / Metformin Extended-Release Tablet; Drug: Synjardy XR tablets |
| Synjardy XR tablets | Active comparator | Synjardy XR tablets 25mg/1000mg Receives: Drug: Empagliflozin / Metformin Extended-Release Tablet; Drug: Synjardy XR tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 48 hours
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: 48 hours
Secondary outcomes (2)
Time to reach maximum concentration Cmax (Tmax)
Descriptive Statistics
Measured: 48 hours
Area under the plasma concentration versus time curve from time 0 to 24 hour (AUC0-24)
Descriptive Statistics
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start7 May 2026
- Primary completion29 Jun 2026
- Study completion1 Jul 2026
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
- NCT07694115
- Sponsor's protocol ID
- 26-VIN-0091
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 9 Jul 2026
- 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 9 Jul 2026. 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 to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg in Fasting Condition.
- ClinicalTrials.gov ID
- NCT07694115
- Acronym / sponsor ID
- 26-VIN-0091
- 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
- 7 May 2026 (actual)
- Primary completion
- 29 Jun 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 9 Jul 2026 (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, randomized, two-period, two treatment, two-sequence, crossover, balanced, single dose oral bioequivalence study to compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet versus Synjardy XR tablets 25mg/1000mg in healthy subject in fasting condition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin / Metformin Extended-Release Tablet | Experimental | Drug: Empagliflozin / Metformin Extended-Release Tablet, Drug: Synjardy XR tabletsEmpagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet |
| Synjardy XR tablets | Active comparator | Drug: Empagliflozin / Metformin Extended-Release Tablet, Drug: Synjardy XR tabletsSynjardy XR tablets 25mg/1000mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Participants aged between 18 to 45 years (both inclusive).
- Participants' 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.
- Participants with normal health as determined by personal medical history, clinical examination and laboratory examinations within Predefined site Normal range [Annexure III].
- Participants having clinically acceptable 12-lead electrocardiogram (ECG).
- Participants 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 Extended-Release Tablet1 extended Release tablet of Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet | Drug | Empagliflozin / Metformin Extended-Release Tablet, Synjardy XR tablets |
| Synjardy XR tablets1 extended Release tablet of Synjardy XR tablets 25mg/1000mg | Drug | Empagliflozin / Metformin Extended-Release Tablet, Synjardy XR tablets |
Primary outcome
Maximum concentration obtained (Cmax)
Time frame: 48 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
AUC from time 0 to last collection time (AUC0 - t)
Time frame: 48 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
Time to reach maximum concentration Cmax (Tmax)
Time frame: 48 hours
Area under the plasma concentration versus time curve from time 0 to 24 hour (AUC0-24)
Time frame: 48 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 9 Jul 2026.
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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 Extended-Release Tablet and Synjardy XR 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 9 Jul 2026. 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?
Maximum concentration obtained (Cmax) (time frame: 48 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 9 Jul 2026.