Type 2 Diabetes Mellitus (T2DM)Phase 1NCT07872358
Bioequivalence Study to Compare Empagliflozin/Linagliptin/Metformin HCl25 mg/5 mg/1000 mg Extended Release Tablet Versus Trijardy® XR 25 mg/5 mg/1000 mg Extended- Release Tablets
A Phase 1 study testing Empagliflozin/Linagliptin/Metformin HCl Extended Release Tablet and Trijardy® XR Tablets in people with Type 2 Diabetes Mellitus (T2DM) and Cardiovascular Diseases, 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/ Linagliptin/ Metformin HCl 25 mg/5 mg/1000 mg Extended Release Tablet versus Trijardy® XR (Empagliflozin/linagliptin/metformin hydrochloride extended-release tablets… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Cardiovascular Diseases
- What is being tested?
- Empagliflozin/Linagliptin/Metformin HCl Extended Release Tablet and Trijardy® XR Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndia
- Study dates
- 7 Jun 2026to 7 Oct 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 to 55 years old, both inclusive.
- Gender: Male and/or non-pregnant, non-lactating female. A. Female of child-bearing potential had a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days of the first dose of study medication. They used an acceptable form of contraception.For female of child-bearing potential, acceptable forms of contraception included the following:i. Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, orii. Barrier methods containing or used in conjunction with a spermicidal agent, oriii. Surgical sterilization oriv. Practicing sexual abstinence throughout the course of the study.B. Females were not considered of child-bearing potential if one of the following was reported and documented on the medical history:i. Postmenopausal with spontaneous amenorrhea for at least 12 consecutive months without other medical explanation, orii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, oriii. Total hysterectomy and an absence of bleeding for at least 3 months.
- 18.5 to 30.0 kg/m2, both inclusive; BMI values were rounded off to one significant digit after decimal point (e.g. 30.04 rounded down to 30.0, while 18.45 rounded up to 18.5).
- Able to communicate effectively with study personnel.
- Non-alcoholic, non-smoker and non-tobacco user (i.e. had no past history of drinking alcohol, smoking and tobacco consuming for at least one year prior tostudy).
- Normal or clinically non-significant ECG recording during screening.
- Willing to provide written informed consent to participate in the study.
- All participants were judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 daysof the first dose of study medication which included:a) A physical examination (clinical examination) with no clinically significantfinding.
Who cannot join
- History of allergic responses to Empagliflozin, Linagliptin, Metformin or other related drugs, or any of its formulation ingredients.
- Had significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG recording, gynecological history and examination (including pelvic examination and routine breast examination) (for female participants)].
- Any disease or condition like diabetes, psychosis or others, which compromised the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, Central nervous system or any other body system.
- History or presence of bronchial asthma.
- Used any hormone replacement therapy within 3 months prior to the first dose of study medication.
- Used any depot injection or implant of any drug within 3 months prior to the first dose of study medication.
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- Used CYP enzyme inhibitors or inducers within 30 days prior to the first dose of study medication (see https://drug-interactions.medicine.iu.edu/MainTable.aspx).
- History or evidence of drug dependence.
- History of difficulty with donating blood or difficulty in accessibility of veins.
- A positive hepatitis screen (included subtypes B \& C).
- A positive test result for HIV antibody.
- Participant who had received a known investigational drug within seven elimination half-life of the administered drug prior to the first dose of study medication.
- Participant who had donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or >200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever was greater.
- History of difficulty in swallowing or of any gastrointestinal disease, which affected drug absorption.
- Intolerance to venipuncture.
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the participant's participation in this study.
- Institutionalized participant.
- Used any prescribed medications within 14 days prior to the first dose of study medication.
- Used any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication.
- Used grapefruit and grapefruit containing products within 7 days prior to the first dose of study medication.
- Ingested any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeinecontaining sodas, colas, etc.), recreational drugs within 48 hours prior to the first dose of study medication.
- Ingested any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication.
- Presence of ketone during urine analysis.
- History or presence of cardiovascular disorders.
- Participant with Serum Lactate higher than upper limit of normal range.
- Participant with Estimated Glomerular Filtration Rate was less than 60 ml/min/1.73 m2 during screening.
- History or presence of hypoglycemia.
- Participant with Serum Creatinine higher than upper limit of normal range.
- History of acute and chronic metabolic acidosis.
- History or sign and symptoms of pancreatitis.
- History of genital mycotic infections.
- History of severe and disabling arthralgia.
- History of bullous pemphigoid.
- History of recurrent urinary tract infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, Two-period, Two Treatment, Two-sequence, Crossover, Balanced, Single Dose Oral Bioequivalence Study to Compare Empagliflozin/ Linagliptin/ Metformin HCl 25 mg/5 mg/1000 mg Extended Release Tablet Versus Trijardy® XR (Empagliflozin, Linagliptin, and Metformin Hydrochloride Extended-release Tablets) 25 mg/5 mg/1000 mg in Fast Condition.
An open label, randomized, two-period, two treatment, two-sequence, crossover, balanced, single dose oral bioequivalence study to compare Empagliflozin/ Linagliptin/ Metformin HCl 25 mg/5 mg/1000 mg Extended Release Tablet versus Trijardy® XR (Empagliflozin/linagliptin/metformin hydrochloride extended-release tablets 25 mg/5 mg/1000 mg) in healthy subject in fast condition.
- Being tested
- Empagliflozin/Linagliptin/Metformin HCl Extended Release Tablet, Trijardy® XR Tablets
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin/Linagliptin/Metformin HCl Extended Release TabletDrug
1 extended Release tablet of Empagliflozin/Linagliptin/Metformin HCl 25 mg/5 mg/1000 mg
Trijardy® XR TabletsDrug
1 extended Release tablet of Empagliflozin/Linagliptin/Metformin HCl 25 mg/5 mg/1000 mg
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin/Linagliptin/Metformin HCl Extended Release Tablet | Experimental | Empagliflozin/Linagliptin/Metformin HCl 25 mg/5 mg/1000 mg Extended Release Tablet Receives: Drug: Empagliflozin/Linagliptin/Metformin HCl Extended Release Tablet; Drug: Trijardy® XR Tablets |
| Trijardy® XR extended-release tablets | Active comparator | Trijardy® XR (Empagliflozin/linagliptin/metformin hydrochloride extended-release tablets 25 mg/5 mg/1000 mg) Receives: Drug: Empagliflozin/Linagliptin/Metformin HCl Extended Release Tablet; Drug: Trijardy® XR Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
For Empagliflozin & Linagliptin & 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: Empagliflozin & Metformin; 48 hours, Linagliptin; 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: Empagliflozin & Metformin: 48 hours
For Linagliptin; Area under the plasma concentration-time curve from 0 to 72 hours (AUC72)
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 (3)
For Empagliflozin & Linagliptin & Metformin; Time to reach maximum concentration Cmax (Tmax
Descriptive Statistics
Measured: Empagliflozin & Metformin: 48 hours, Linagliptin: 72 hours
For Metformin : Area under the plasma concentration versus time curve from the zero time point to the last quantifiable concentration(AUCt)
Descriptive Statistics
Measured: 48 hours
For Empagliflozin: Area under the plasma concentration versus time curve from zero to infinity (AUCi)
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 posted13 Oct 2026
- Study start7 Jun 2026
- Primary completion30 Jul 2026
- Study completion7 Oct 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
- 36 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
- NCT07872358
- Sponsor's protocol ID
- C1B06323
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 13 Oct 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Two-period, Two Treatment, Two-sequence, Crossover, Balanced, Single Dose Oral Bioequivalence Study to Compare Empagliflozin/ Linagliptin/ Metformin HCl 25 mg/5 mg/1000 mg Extended Release Tablet Versus Trijardy® XR (Empagliflozin, Linagliptin, and Metformin Hydrochloride Extended-release Tablets) 25 mg/5 mg/1000 mg in Fast Condition.
- ClinicalTrials.gov ID
- NCT07872358
- Acronym / sponsor ID
- C1B06323
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Humanis Saglık Anonim SirketiIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2026 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 7 Oct 2026 (actual)
- First posted
- 13 Oct 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/ Linagliptin/ Metformin HCl 25 mg/5 mg/1000 mg Extended Release Tablet versus Trijardy® XR (Empagliflozin/linagliptin/metformin hydrochloride extended-release tablets 25 mg/5 mg/1000 mg) in healthy subject in fast condition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin/Linagliptin/Metformin HCl Extended Release Tablet | Experimental | Drug: Empagliflozin/Linagliptin/Metformin HCl Extended Release Tablet, Drug: Trijardy® XR TabletsEmpagliflozin/Linagliptin/Metformin HCl 25 mg/5 mg/1000 mg Extended Release Tablet |
| Trijardy® XR extended-release tablets | Active comparator | Drug: Empagliflozin/Linagliptin/Metformin HCl Extended Release Tablet, Drug: Trijardy® XR TabletsTrijardy® XR (Empagliflozin/linagliptin/metformin hydrochloride extended-release tablets 25 mg/5 mg/1000 mg) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age: 18 to 55 years old, both inclusive.
- Gender: Male and/or non-pregnant, non-lactating female. A. Female of child-bearing potential had a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days of the first dose of study medication. They used an acceptable form of contraception.For female of child-bearing potential, acceptable forms of contraception included the following:i. Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, orii. Barrier methods containing or used in conjunction with a spermicidal agent, oriii. Surgical sterilization oriv. Practicing sexual abstinence throughout the course of the study.B. Females were not considered of child-bearing potential if one of the following was reported and documented on the medical history:i. Postmenopausal with spontaneous amenorrhea for at least 12 consecutive months without other medical explanation, orii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, oriii. Total hysterectomy and an absence of bleeding for at least 3 months.
- 18.5 to 30.0 kg/m2, both inclusive; BMI values were rounded off to one significant digit after decimal point (e.g. 30.04 rounded down to 30.0, while 18.45 rounded up to 18.5).
- Able to communicate effectively with study personnel.
- Non-alcoholic, non-smoker and non-tobacco user (i.e. had no past history of drinking alcohol, smoking and tobacco consuming for at least one year prior tostudy).
Key exclusion criteria (34 listed)
- History of allergic responses to Empagliflozin, Linagliptin, Metformin or other related drugs, or any of its formulation ingredients.
- Had significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG recording, gynecological history and examination (including pelvic examination and routine breast examination) (for female participants)].
- Any disease or condition like diabetes, psychosis or others, which compromised the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, Central nervous system or any other body system.
- History or presence of bronchial asthma.
- Used any hormone replacement therapy within 3 months prior to the first dose of study medication.
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/Linagliptin/Metformin HCl Extended Release Tablet1 extended Release tablet of Empagliflozin/Linagliptin/Metformin HCl 25 mg/5 mg/1000 mg | Drug | Empagliflozin/Linagliptin/Metformin HCl Extended Release Tablet, Trijardy® XR extended-release tablets |
| Trijardy® XR Tablets1 extended Release tablet of Empagliflozin/Linagliptin/Metformin HCl 25 mg/5 mg/1000 mg | Drug | Empagliflozin/Linagliptin/Metformin HCl Extended Release Tablet, Trijardy® XR extended-release tablets |
Primary outcome
For Empagliflozin & Linagliptin & Metformin; Maximum concentration obtained (Cmax)
Time frame: Empagliflozin & Metformin; 48 hours, Linagliptin; 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: Empagliflozin & Metformin: 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
For Linagliptin; Area under the plasma concentration-time curve from 0 to 72 hours (AUC72)
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
3 secondary outcomes
For Empagliflozin & Linagliptin & Metformin; Time to reach maximum concentration Cmax (Tmax
Time frame: Empagliflozin & Metformin: 48 hours, Linagliptin: 72 hours
For Metformin : Area under the plasma concentration versus time curve from the zero time point to the last quantifiable concentration(AUCt)
Time frame: 48 hours
For Empagliflozin: Area under the plasma concentration versus time curve from zero to infinity (AUCi)
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 13 Oct 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/Linagliptin/Metformin HCl Extended Release Tablet and Trijardy® XR Tablets in people with Type 2 Diabetes Mellitus (T2DM) and Cardiovascular Diseases, 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 8 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 13 Oct 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?
For Empagliflozin & Linagliptin & Metformin; Maximum concentration obtained (Cmax) (time frame: Empagliflozin & Metformin; 48 hours, Linagliptin; 72 hours). The study lists 3 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 13 Oct 2026.