Bioequivalence Study to Compare Empagliflozin/Linagliptin/Metformin HCl 25 mg/5 mg/1000 mg Extend… (NCT07691203) | Clinical Trial Compass
CompletedPhase 1
Bioequivalence Study to Compare Empagliflozin/Linagliptin/Metformin HCl 25 mg/5 mg/1000 mg Extended Release Tablet Versus Trijardy® XR 25 mg/5 mg/1000 mg Extended- Release Tablets
India36 participantsStarted 2026-03-07
Plain-language 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 25 mg/5 mg/1000 mg) in healthy subject in fed condition.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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, or ii. Barrier methods containing or used in conjunction with a spermicidal agent, or iii. Surgical sterilization or iv. 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, or ii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iii. 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 u…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was comparing a generic version of Trijardy XR to the brand-name version — does that mean the brand-name Trijardy XR is already an established option my doctor might consider prescribing me right now, outside of any trial?
2Since this was a Phase 1 bioequivalence study focused on how the body absorbs the drug rather than on patient outcomes, what does that tell us about how much safety and effectiveness data actually exists for the combination of empagliflozin, linagliptin, and metformin in people with my specific situation?
3The trial measured drug concentration levels like Cmax and AUC to check if the two tablet versions behave the same in the body — if the generic version was found to be bioequivalent, would that affect which version I might be offered, and does it matter which one I take?
4Given that this study is already completed, would my doctor be able to access any results showing whether the generic formulation matched Trijardy XR, and how would those results factor into a treatment decision for me?
5This combination drug targets both blood sugar control and cardiovascular risk — given my own cardiovascular history or risk factors, is a triple-combination pill like this something worth discussing as a treatment path, or would my doctor recommend starting with one medication at a time?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
For Empagliflozin & Linagliptin & Metformin; Maximum concentration obtained (Cmax)