Generic diabetes combo pill put to the test
NCT ID NCT07213895
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compared a generic combination tablet containing three diabetes drugs (empagliflozin, linagliptin, and metformin) to the brand-name Trijardy XR. Fourteen healthy adults took a single dose of each under fed conditions to see if the generic is absorbed at the same rate and amount. The goal is to confirm bioequivalence, which could lead to a lower-cost option for managing type 2 diabetes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Empagliflozin, Linagliptin, and Metformin (extended-release combination tablet)
- What this could lead to
- If successful, this could lead to a more affordable generic version of the diabetes combination pill Trijardy XR.
- What could go wrong
- This is a small, early-phase study in healthy people, not patients. It only checks if the generic is absorbed similarly, not if it works better or is safer long-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
14 people
The number who actually took part.
- Started
-
May 2025
- Finished
-
Sep 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 50 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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ACDIMA Center
Amman, 925161, Jordan
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