Can a cheaper copy match the original diabetes pill?
NCT ID NCT07763912
First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This trial compares two oral medications containing sitagliptin and metformin in extended-release tablets. The goal is to see if the test version is absorbed in the body the same way as the reference product, a process called bioequivalence. Healthy adults aged 18 to 55 will receive a single dose of each medication under fed conditions, with blood samples taken to measure drug levels. The study uses a crossover design, meaning each participant gets both treatments at different times, to ensure a fair comparison.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sitagliptin/metformin extended-release tablet
- What this could lead to
- If the generic tablet proves bioequivalent, it could offer a more affordable alternative to the brand-name diabetes medication, expanding patient access.
- What could go wrong
- This is a small, early-stage study in healthy volunteers, not patients. Results may not predict real-world effectiveness or safety in people with diabetes.
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
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
46 people
The number who actually took part.
- Started
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Nov 2025
- Finished
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Dec 2025
- Lead sponsor
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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 55 years
- Sex
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Anyone
- Healthy volunteers
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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: 1. Age between 18 and 55 years. 2. Clinically healthy according to the updated medical history prior to the start of the study. 3. Not blocked in the COFEPRIS research subject database. 4. Body mass index between 18 and 27 kg/m². 5. Normal vital signs: Heart rate between 60 and 99 beats per minute, respiratory rate between 12 and 20 breaths per minute, systolic blood pressure between 90-130 mmHg, diastolic blood pressure between 60-89 mmHg, and temperature between 36.0 and 37.4°C. 6. Electrocardiogram (ECG) without any signs of pathology. 7. Clinical laboratory test results within normal limits or with clinically insignificant variations. 8. Negative biosafety tests for the presence of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and varicella-zoster virus (VDRL). 9. Negative drug screening tests for amphetamines, benzodiazepines, cocaine, methamphetamines, morphine, and tetrahydrocannabinol (THC). 10. Negative qualitative pregnancy test (for women). 11. Negative breath alcohol test. 12. Research subjects with no history of alcohol abuse or dependence, psychoactive substance abuse, or chronic medication use. 13. Subjects with a signed informed consent form and a signed non-pregnancy commitment letter. 14. Women who are not pregnant or breastfeeding. 15. Women using at least one method of family planning deemed safe by the principal investigator. Exclusion Criteria: 1. Subjects with a history of hypersensitivity to the study drug. 2. Subjects with lactose intolerance. 3. Subjects with a history of cardiovascular, renal, hepatic, metabolic, gastrointestinal, neurological, endocrine, hematopoietic (any type of anemia), mental illness, or other organic abnormalities that could affect the pharmacokinetic study of the study product. 4. Subjects requiring any medication during the course of the study that interferes with the quantification or pharmacokinetics of the study drug. 5. Subjects who have been exposed to agents known to induce or inhibit hepatic enzyme systems or who have taken potentially toxic medications within 30 days prior to the start of the study. 6. Subjects who, prior to receiving the study drug, have taken medications such as those described in section 3.11 "Drug Interactions." 7. Subjects who have been hospitalized for any reason within sixty days prior to the start of the study or who have been seriously ill within thirty days prior to the start of the study. 8. Subjects who have received an investigational drug within ninety days prior to the start of the study. 9. Subjects who have donated or lost 450 mL or more of blood within sixty days prior to the start of the study. 10. Research subjects with a history of alcohol or psychoactive substance abuse or dependence, or chronic medication use. 11. Subjects who have consumed beverages or foods containing xanthines (coffee, tea, cocoa, chocolate, yerba mate, cola, etc.) or have consumed charcoal-grilled foods within 12 hours prior to administration of the medication dose. 12. Subjects who have consumed grapefruit, cranberry, or pomegranate juice within 12 hours prior to the study. 13. Subjects who have smoked at least 12 hours before the start of the study. 14. Subjects who have ingested alcoholic beverages 48 hours prior to administration of the dose. 15. Positive (qualitative) pregnancy test.
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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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Axis Clinicals Latina, S.A. de C.V.
Mexico City, Mexico City, 07870, Mexico
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