Generic diabetes pill put to the test: will it match the brand?
NCT ID NCT07679711
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This trial tests whether a new generic extended-release tablet containing sitagliptin and metformin works the same in the body as the brand-name version (Janumet XR). Healthy Chinese adults receive a single dose of each tablet, separated by a washout period, under both fasting and fed conditions. Blood samples are taken to measure drug levels and check for safety. The goal is to see if the generic can be considered a suitable substitute for the brand.
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 hydrochloride extended-release tablet
- What this could lead to
- If the test tablet proves equivalent to the reference, it could offer a more affordable generic option for managing type 2 diabetes.
- What could go wrong
- This is an early-phase bioequivalence 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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
76 people
The number who actually took part.
- Started
-
Feb 2023
- Finished
-
Mar 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- 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: * Sign the informed consent form before the trial, and fully understand the trial content, process, and possible adverse reactions. * Able to complete the study according to the requirements of the study protocol. * Subjects voluntarily agree to use effective non-pharmacological contraception methods from the signing of informed consent (14 days prior to signing for female subjects) until 3 months after the last dose, with no plans for pregnancy, sperm donation, or egg donation. * Male and female subjects aged 18 years and above. * Male subjects weighing ≥ 50.0 kg and female subjects weighing ≥ 45.0 kg; Body Mass Index (BMI) within the range of 19.0 to 27.0 kg/m\^2 (inclusive). Exclusion Criteria: * History of specific allergies (e.g., urticaria, exfoliative dermatitis, angioedema, or bronchial hyperresponsiveness), or allergic constitution (e.g., allergic to two or more drugs, foods such as milk and pollen), or known allergy to the components or analogs of this drug. * Serious history of cardiovascular, hepatic, renal, gastrointestinal, neurological, endocrine, respiratory, or psychiatric abnormalities, which the investigator considers inappropriate for participation. * Clinically significant abnormal findings as judged by the investigator, including physical examination, vital signs, electrocardiogram, or clinical laboratory tests. * History of or current pancreatitis. * History of hypoglycemia. * Estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73 m\^2. * History of dysphagia or any gastrointestinal disease affecting drug absorption (e.g., gastric or small bowel resection, atrophic gastritis, gastrointestinal bleeding, obstruction, etc.). * Difficulty in blood collection, intolerance to venipuncture, or history of needle/blood phobia. * Female subjects who are pregnant, lactating, or have a positive pregnancy test result. * Positive for any one or more of the following: Hepatitis B surface antigen, Hepatitis C antibody, HIV antibody, or Syphilis antibody. * History of drug abuse within 5 years, use of illicit drugs within 3 months prior to screening, or positive urine drug screen. * Consumption of more than 14 units of alcohol per week on average within 3 months prior to screening, or refusal to abstain from alcohol from 48 hours prior to dosing in each period until the end of blood collection for that period, or positive alcohol breath test. * Smoking more than 5 cigarettes per day on average within 3 months prior to screening, or refusal to abstain from using any tobacco products during the clinical stay. * History of surgery within 3 months prior to screening, or planned surgery during the study. * Blood donation or massive blood loss (\>400 mL, excluding physiological blood loss in females) within 3 months prior to the first dose, or donation of 2 therapeutic units of platelets within 1 month. * Participation and drug administration in any clinical trial within 3 months prior to the first dose. * Use of any prescription drugs within 14 days prior to dosing. * Use of any over-the-counter drugs, herbal medicines, or dietary supplements within 7 days prior to dosing. * Consumption of special diets (e.g., grapefruit and products containing grapefruit ingredients) or strenuous exercise within 48 hours prior to dosing, or other factors affecting drug absorption, distribution, metabolism, and excretion. * Consumption of any xanthine-rich foods or beverages (e.g., coffee, tea, chocolate, cocoa, milk tea, etc.) within 48 hours prior to dosing. * Special dietary requirements, inability to comply with the diet and corresponding regulations provided by the center. * Occurrence of an acute illness during the pre-study screening phase or before study drug administration. * Other subjects deemed unsuitable for participation by the investigator.
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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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The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000, China
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