Generic diabetes pill put to the test against Brand-Name drug
NCT ID NCT07694115
First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time
Summary
This trial compares a generic extended-release tablet containing empagliflozin and metformin to the brand-name Synjardy XR. Healthy adults aged 18 to 45 receive a single dose of each version in random order, and researchers measure drug levels in the blood to see if the generic works the same. The goal is to confirm bioequivalence, which could lead to a more affordable 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 and metformin extended-release tablet
- What this could lead to
- If the generic tablet proves equivalent, it could offer a more affordable treatment option for people with type 2 diabetes.
- What could go wrong
- This is an early-phase study in healthy volunteers, not patients. It only measures drug levels in the blood, not actual diabetes control or long-term safety.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
40 people
The number who actually took part.
- Started
-
May 2026
- Finished
-
Jul 2026
- 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 45 years
- Sex
-
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: * 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), 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 * Participants having negative urine pregnancy test at screening and negative serum beta-hCG pregnancy test on admission day of period 01 (only for female participants). Exclusion Criteria: * Hypersensitivity to Empagliflozin and Metformin 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. * Presence of alcoholism or drug abuse. * History or presence of asthma, urticaria or other significant allergic reactions. * History or presence of significant gastric and/or duodenal ulceration. * 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. * Participant 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. * Participants who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study. * History of any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis). * History of Diabetic pre-coma. * History of acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock. * History of disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: decompensated heart failure, respiratory failure, recent myocardial infarction, shock. * History of Hepatic impairment or acute alcohol intoxication. * Female participants who are currently breast feeding.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Type 2 diabetes mellitus (T2DM) are added.
By submitting, you agree to our Terms of use
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
-
Veeda Clinical Research Ltd.
Ahmedabad, Ambawadi, 380 015, India
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Four pills, one goal: can a new combo tame type 2 diabetes?
- Can banding the gut tame type 2 diabetes?
- Can QR codes and videos teach better foot care?
- Can a new injection help tackle obesity? a trial puts MWN105 to the test
- Can when you eat change how a diabetes drug works?
- Can a new daily pill outperform semaglutide for diabetes?