Type 2 Diabetes Mellitus (T2DM)Phase 1NCT06932159
Bioequivalence Study to Compare Empagliflozin + Linagliptin 25 mg/5 mg Film-coated Tablets Versus Glyxambi 25 mg/ 5 mg Film-coated Tablets
A Phase 1 study testing Empagliflozin + Linagliptin film-coated tablets and Glyxambi film-coated 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 in healthy, adult, human subjects under 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 + Linagliptin film-coated tablets and Glyxambi film-coated 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
- 23 Dec 2024to 8 Apr 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
- 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 the clinically acceptable range.
- Subject with Creatinine Clearance ≥80 ml/min.
- Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
- Subjects having clinically acceptable chest X-Ray (PA view), if taken.
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- Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
- 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.
- 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 β-hCG pregnancy test on admission day of period 01 (only for female subjects).
Who cannot join
- Hypersensitivity to Empagliflozin \& Linagliptin 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.
- History or presence of alcoholism or drug abuse.
- History of any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) 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 acute conditions with the potential to alter renal function.
- 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 in Healthy, Adult, Human Subjects Under Fasting Condition
An open label, balanced, randomized, single dose, two treatment, two sequence, two period, two way crossover oral bioequivalence study in healthy, adult, human subjects under fasting condition.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Empagliflozin + Linagliptin film-coated tablets, Glyxambi film-coated 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 + Linagliptin film-coated tabletsDrug
1 tablet of Empagliflozin + Linagliptin 25 mg/5 mg film-coated tablets
Glyxambi film-coated tabletsDrug
1 tablet of Glyxambi 25 mg/ 5 mg film-coated tablets
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin + Linagliptin film-coated tablets | Experimental | Empagliflozin + Linagliptin 25 mg/5 mg film-coated tablets Receives: Drug: Empagliflozin + Linagliptin film-coated tablets; Drug: Glyxambi film-coated tablets |
| Glyxambi film-coated tablets | Active comparator | Glyxambi 25 mg/ 5 mg film-coated tablets Receives: Drug: Empagliflozin + Linagliptin film-coated tablets; Drug: Glyxambi film-coated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
For Empagliflozin; Peak Plasma Concentration (Cmax)
The 90% confidence intervals for the difference between least square means of test (T) and reference (R) formulations will be calculated using mean square error, obtained in ANOVA, for ln-transformed pharmacokinetic parameters Cmax and AUC0-t for Empagliflozin \& Cmax and AUC0-72 for Linagliptin.
Measured: 72 hours
For Empagliflozin; The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration, calculated using linear trapezoidal method (AUC0-t)
The 90% confidence intervals for the difference between least square means of test (T) and reference (R) formulations will be calculated using mean square error, obtained in ANOVA, for ln-transformed pharmacokinetic parameters Cmax and AUC0-t for Empagliflozin \& Cmax and AUC0-72 for Linagliptin
Measured: 72 hours
For Linagliptin; Peak Plasma Concentration (Cmax)
The 90% confidence intervals for the difference between least square means of test (T) and reference (R) formulations will be calculated using mean square error, obtained in ANOVA, for ln-transformed pharmacokinetic parameters Cmax and AUC0-t for Empagliflozin \& Cmax and AUC0-72 for Linagliptin
Measured: 72 hours
For Linagliptin; Area Under the Curve from time zero to time of last measurable concentration (AUC0-72)
The 90% confidence intervals for the difference between least square means of test (T) and reference (R) formulations will be calculated using mean square error, obtained in ANOVA, for ln-transformed pharmacokinetic parameters Cmax and AUC0-t for Empagliflozin \& Cmax and AUC0-72 for Linagliptin
Measured: 72 hours
Secondary outcomes (3)
For Empagliflozin; Area Under the Curve from time zero to time infinite (AUC0-∞)
Descriptive Statistic
Measured: 72 hours
For Empagliflozin; Time to reach peak plasma concentration (Tmax)
Descriptive Statistic
Measured: 72 hours
For Linagliptin; Time to reach peak plasma concentration (Tmax)
Descriptive Statistic
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 posted17 Apr 2025
- Study start23 Dec 2024
- Primary completion7 Mar 2025
- Study completion8 Apr 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
- NCT06932159
- Sponsor's protocol ID
- 24-VIN-0555
- Status last verified
- Dec 2024
- First submitted
- 10 Apr 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 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 in Healthy, Adult, Human Subjects Under Fasting Condition
- ClinicalTrials.gov ID
- NCT06932159
- Acronym / sponsor ID
- 24-VIN-0555
- 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
- 23 Dec 2024 (actual)
- Primary completion
- 7 Mar 2025 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 17 Apr 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 in healthy, adult, human subjects under fasting condition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin + Linagliptin film-coated tablets | Experimental | Drug: Empagliflozin + Linagliptin film-coated tablets, Drug: Glyxambi film-coated tabletsEmpagliflozin + Linagliptin 25 mg/5 mg film-coated tablets |
| Glyxambi film-coated tablets | Active comparator | Drug: Empagliflozin + Linagliptin film-coated tablets, Drug: Glyxambi film-coated tabletsGlyxambi 25 mg/ 5 mg film-coated tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 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 the clinically acceptable range.
- Subject with Creatinine Clearance ≥80 ml/min.
- Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
Key exclusion criteria (21 listed)
- Hypersensitivity to Empagliflozin \& Linagliptin 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.
- History or presence of alcoholism or drug abuse.
- History of any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) 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 + Linagliptin film-coated tablets1 tablet of Empagliflozin + Linagliptin 25 mg/5 mg film-coated tablets | Drug | Empagliflozin + Linagliptin film-coated tablets, Glyxambi film-coated tablets |
| Glyxambi film-coated tablets1 tablet of Glyxambi 25 mg/ 5 mg film-coated tablets | Drug | Empagliflozin + Linagliptin film-coated tablets, Glyxambi film-coated tablets |
Primary outcome
For Empagliflozin; Peak Plasma Concentration (Cmax)
Time frame: 72 hours
The 90% confidence intervals for the difference between least square means of test (T) and reference (R) formulations will be calculated using mean square error, obtained in ANOVA, for ln-transformed pharmacokinetic parameters Cmax and AUC0-t for Empagliflozin \& Cmax and AUC0-72 for Linagliptin.
For Empagliflozin; The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration, calculated using linear trapezoidal method (AUC0-t)
Time frame: 72 hours
The 90% confidence intervals for the difference between least square means of test (T) and reference (R) formulations will be calculated using mean square error, obtained in ANOVA, for ln-transformed pharmacokinetic parameters Cmax and AUC0-t for Empagliflozin \& Cmax and AUC0-72 for Linagliptin
For Linagliptin; Peak Plasma Concentration (Cmax)
Time frame: 72 hours
The 90% confidence intervals for the difference between least square means of test (T) and reference (R) formulations will be calculated using mean square error, obtained in ANOVA, for ln-transformed pharmacokinetic parameters Cmax and AUC0-t for Empagliflozin \& Cmax and AUC0-72 for Linagliptin
For Linagliptin; Area Under the Curve from time zero to time of last measurable concentration (AUC0-72)
Time frame: 72 hours
The 90% confidence intervals for the difference between least square means of test (T) and reference (R) formulations will be calculated using mean square error, obtained in ANOVA, for ln-transformed pharmacokinetic parameters Cmax and AUC0-t for Empagliflozin \& Cmax and AUC0-72 for Linagliptin
3 secondary outcomes
For Empagliflozin; Area Under the Curve from time zero to time infinite (AUC0-∞)
Time frame: 72 hours
For Empagliflozin; Time to reach peak plasma concentration (Tmax)
Time frame: 72 hours
For Linagliptin; Time to reach peak plasma concentration (Tmax)
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 17 Apr 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 + Linagliptin film-coated tablets and Glyxambi film-coated 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 16 inclusion and 21 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 17 Apr 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; Peak Plasma Concentration (Cmax) (time frame: 72 hours). The study lists 4 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 17 Apr 2025.