CompletedPhase 1

Bioequivalence Study to Compare Empagliflozin/ Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg

India40 participantsStarted 2026-05-07

Plain-language summary

An open label, randomized, two-period, two treatment, two-sequence, crossover, balanced, single dose oral bioequivalence study to compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet versus Synjardy XR tablets 25mg/1000mg in healthy subject in fasting condition.

Who can participate

Age range

18 Years – 45 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: * Participants aged between 18 to 45 years (both inclusive). * Participants' 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. * Participants with normal health as determined by personal medical history, clinical examination and laboratory examinations within Predefined site Normal range \[Annexure III\]. * Participants having clinically acceptable 12-lead electrocardiogram (ECG). * Participants having clinically acceptable chest X-Ray (PA view), if taken. * Participants having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine). * Participants having negative urine alcohol test / breath alcohol test. * Non-smoker. * Participants willing to adhere to the protocol requirements and to provide written informed consent. * Participant with Creatinine Clearance ˃60 ml/min. * For male Participants: Participants 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. Participants willing to refrain from donating sperm during the study period * For Female Participants: Female of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s),…

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 testing whether a generic version of the empagliflozin/metformin extended-release combination (Synjardy XR 25mg/1000mg) behaves the same way in the body as the brand-name version — could this mean a lower-cost generic option might become available for me, and is that something worth watching for?
2Since this was a Phase 1 bioequivalence study focused on how the drug is absorbed (things like peak concentration and overall exposure), it wasn't designed to prove new benefits or uncover new risks — does that change how you'd interpret its findings compared to larger treatment trials I might come across?
3The trial is already completed, so the data should exist — is there a way to see the results, and would those results affect whether you'd consider prescribing this combination of empagliflozin and metformin for my type 2 diabetes?
4Synjardy XR combines two diabetes medications in one extended-release tablet — given my specific situation, do you think a combination pill like this would be a reasonable option for me compared to taking separate medications, and what are the trade-offs?
5Before I consider anything related to this drug combination, are there standard first-line treatments for my type 2 diabetes that I should try first, or is a combination of empagliflozin and metformin already appropriate for where I am in my treatment journey?

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

Maximum concentration obtained (Cmax)

Timeframe: 48 hours

AUC from time 0 to last collection time (AUC0 - t)

Timeframe: 48 hours

Trial details

NCT IDNCT07694115

SponsorHumanis Saglık Anonim Sirketi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-29

View on ClinicalTrials.gov More Type 2 Diabetes Mellitus (T2DM) trials

Who can participate

Age range

18 Years – 45 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.