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Type 2 Diabetes Mellitus (T2DM)Phase 1NCT07213895

Bioequivalence Study to Compare Empagliflozin/Linagliptin/Metformin HCL 25mg/5mg/1000mg Extended-Release Tablets Versus Trijardy® XR Extended Release Film Coated Tablets

A Phase 1 study testing Empagliflozin/Linagliptin/Metformin HCL and Trijardy® XR Extended release film coated tablets in people with Type 2 Diabetes Mellitus (T2DM), run by Humanis Saglık Anonim Sirketi at 1 site in Jordan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Randomized, Single Oral Dose, Two-period, Two Sequence, Open-label, Crossover, Bioequivalence Study to Compare Empagliflozin-Linagliptin-Metformin XR Tablet 25mg/ 5mg/1000mg (25mg Empagliflozin /5mg Linagliptin /1000mgMetformin Hydrochloride) Versus Trijardy® XR Tablets (25mg Empagliflozin /5mg Linagliptin /1000mg… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus (T2DM)
What is being tested?
Empagliflozin/Linagliptin/Metformin HCL and Trijardy® XR Extended release film coated tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteJordan
Study dates
21 May 2025to 18 Sep 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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The subject is caucasian \& aged between eighteen \& fifty years (18-50), both inclusive.
  • The subject is within the limits for his/her height \& weight as defined by the body mass index range (18.5 - 30.0 kg/m2).
  • The subject is willing to undergo the necessary pre- \& post- medical examinations set by this study.
  • The results of medical history, physical examination, vital signs \& conducted medical laboratory tests are normal as determined by the clinical investigator.
  • The subject tested negative for Hepatitis B (HBsAg), Hepatitis C (HCVAb) and human immunodeficiency virus (HIVAb).
  • There is no evidence of psychiatric disorder, antagonistic personality, and poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
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  • The subject is able to understand and willing to sign the informed consent form.
  • For female subjects: negative serum pregnancy test and the woman is using two reliable contraception methods and should be non-lactating.
  • The subject has normal cardiovascular system \& normal ECG with normal QT interval corrected for heart rate according to Bazett's formula.
  • The subject's kidney and liver (AST \& ALT enzymes) function tests are within normal range. (Creatinine is accepted if below the reference range after being evaluated by the clinical investigator as clinically not significant).
  • The subject's HbA1c test result is within normal range (HbA1c is accepted if below the reference range after being evaluated by the clinical investigator as clinically not significant.)
  • The subject's fasting blood glucose level is ≥ 70 mg/dL before dosing.
  • The subject Hematology test results are within normal range \& RBC indices are within 5% of the normal range.

Who cannot join

  • The subject is a heavy smoker (more than 10 cigarettes per day).
  • The subject has suffered an acute illness one week before dosing.
  • The subject has a history of or concurrent abuse of alcohol.
  • The subject has a history of or concurrent abuse of illicit drugs.
  • The subject has a history of hypersensitivity and/or contraindications to the study drug and any related compounds.
  • The subject has been hospitalized within three months before the study or during the study.
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  • The subject is on special diet (for example subject is vegetarian).
  • The subject has consumed caffeine or xanthine containing beverages or foodstuffs within two days before dosing and until 72 hours after dosing in both study periods.
  • The subject has taken a prescription medication within two weeks or even an over the counter product (OTC) within one week before dosing in each study period and any time during the study, unless otherwise judged acceptable by the clinical investigator.
  • The subject has taken grapefruit/ orange containing beverages or foodstuffs within seven (7) days before first dosing and any time during the study.
  • The subject has been participating in any clinical study (e.g. pharmacokinetics, bioavailability and bioequivalence studies) within the last 80 days prior to the present study.
  • The subject has donated blood within 80 days before first dosing.
  • The subject has a history or presence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinal, immunological, dermatological, neurological, musculoskeletal or psychiatric diseases.
  • The subject has consumed drugs that may affect pharmacological/ pharmacokinetic properties of Empagliflozin/Linagliptin/Metformin hydrochloride (for example: Ethanol, Ioversol, Probenecid, Iodinated contrast media, Rifampicin, Gemfibrozil, Glimepiride, Sitagliptin, Warfarin, Verapamil, Ramipril, Torasemide, Hydrochlorothiazide, Lithium, Cimetidine, apalutamide, Benazepril, Idelalisib, Ivosidenib, Lasmiditan, Methylene blue, Ranolazine, Selegiline, Tafenoquine, Tedizolid, Tranylcypromine, Tucatinib, Voxelotor, Sulphonylureas, Ritonavir, Dolutegravir, Cimetidine, Trimethoprime, Isavuconazonium, Crizotinib, Olaparib, Trimethoprime, Vandetanib, Isavuconazole, Glucocorticoids, Insulin and insulin secretagogues (Sulphonylureas)) two weeks before and after the study and during the study.
  • The subject has a history of ketone in urine, presence of any type of acute metabolic acidosis (such as lactic acidosis).
  • Note: Subjects, who were screened for another study and were not enrolled, might be recruited for this study provided they meet the acceptance criteria of the study.

Trial locations and contacts

1 site in 1 country.

Jordan1 site

  • ACDIMA Center

    Amman, 925161

Other trials in Jordan

About this study

Official title: Randomized, Single Oral Dose, Two-period, Two Sequence, Open-label, Crossover, Bioequivalence Study to Compare Empagliflozin-Linagliptin-Metformin XR Tablet 25mg/ 5mg/1000mg (25mg Empagliflozin /5mg Linagliptin /1000mg Metformin Hydrochloride) Versus Trijardy® XR Tablets (25mg Empagliflozin /5mg Linagliptin /1000mg Metformin Hydrochloride), in Healthy Subjects Under Fed Conditions.

Randomized, Single Oral Dose, Two-period, Two Sequence, Open-label, Crossover, Bioequivalence Study to Compare Empagliflozin-Linagliptin-Metformin XR Tablet 25mg/ 5mg/1000mg (25mg Empagliflozin /5mg Linagliptin /1000mgMetformin Hydrochloride) Versus Trijardy® XR Tablets (25mg Empagliflozin /5mg Linagliptin /1000mg Metformin Hydrochloride), in Healthy Subjects Under Fed Conditions.

Being tested
Empagliflozin/Linagliptin/Metformin HCL, Trijardy® XR Extended release 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/Metformin HCLDrug

    One Empagliflozin/Linagliptin/Metformin HCL 25mg/5mg/1000mg extended release film-coated tablet

  • Trijardy® XR Extended release film coated tabletsDrug

    One Trijardy® 25mg/5mg/1000mg Extended Release Tablets

Study groups in NCT07213895
Study groupRoleWhat they receive
Empagliflozin/Linagliptin/Metformin HCL Extended Release TabletsExperimentalEmpagliflozin/Linagliptin/Metformin HCL 25mg/5mg/1000mg Extended Release Tablets
Receives: Drug: Empagliflozin/Linagliptin/Metformin HCL; Drug: Trijardy® XR Extended release film coated tablets
Trijardy® XR Extended release film coated tabletsActive comparatorTrijardy® 25mg/5mg/1000mg Extended release film coated tablets
Receives: Drug: Empagliflozin/Linagliptin/Metformin HCL; Drug: Trijardy® XR Extended release film coated tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: 72 hours

  2. For Linagliptin; AUC from time 0 to last collection time (AUC0 - 72 due to Linagliptin long half-life)

    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

  3. For 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 (1)

  1. For Empagliflozin & Linagliptin & Metformin; Time to reach maximum concentration Cmax (Tmax)

    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.

  1. First posted9 Oct 2025
  2. Study start21 May 2025
  3. Primary completion15 Sep 2025
  4. Study completion18 Sep 2025

Resources

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
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07213895
Sponsor's protocol ID
1392-2025, V.01
Status last verified
Oct 2025
First submitted
2 Oct 2025
Last updated
9 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Empagliflozin/Linagliptin/Metformin HCL and Trijardy® XR Extended release film coated tablets in people with Type 2 Diabetes Mellitus (T2DM), run by Humanis Saglık Anonim Sirketi at 1 site in Jordan.

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 16 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 Oct 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 Jordan. 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: 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?

On the ClinicalTrials.gov record for NCT07213895.

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 Oct 2025.

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