Scientists probe gut to see how drugs really dissolve
NCT ID NCT05159427
First seen Jun 24, 2026 · Last updated Jul 21, 2026 · Updated 3 times
Summary
This study aims to understand how a modified-release diabetes drug called glipizide dissolves in the stomach and small intestine. Researchers will directly sample gut contents, blood, urine, and stool from 40 healthy volunteers after they take the drug. The goal is to improve lab models that predict drug dissolution, not to treat any condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Glipizide (a diabetes drug) in extended-release tablets and a stable isotope form
- What this could lead to
- If successful, this could help create better lab tests that predict how drugs dissolve in the human gut, improving future drug development.
- What could go wrong
- This is a very early, small study in healthy people, not patients. It focuses on measuring drug behavior, not treating any disease, so direct benefits are unlikely.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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30 people
The number who actually took part.
- Started
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Mar 2022
- Finished
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Mar 2026
- Lead sponsor
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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
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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. Male or female adults age 18 to 55 years with BMI ranging from 18.5 to 35 kg/m2 inclusive 2. Ability to independently provide an informed consent 3. Demonstrate the ability to swallow a multivitamin pill that mimics a SmartPill capsule 4. Negative serum pregnancy test (for women of child-bearing potential) Exclusion Criteria: 1. Unable to independently provide an informed consent for themselves or mentally incapacitated. 2. Physical disability (including blindness or deafness) that requires special arrangements. 3. Significant clinical illness, including cardiovascular disease, neurological disease, organ failure, or malignancy in the opinion of the investigator 4. Any surgical procedure within 3 weeks prior to screening 5. History and/or presence of severe seasonal allergies or severe allergic diseases including drug allergies, food allergies and allergy against the SmartPill® device 6. History and/or presence of hypersensitivity to any of the study drugs or the products' excipients 7. History and/or presence of hypersensitivity to Sulfonamide derivatives 8. History and/or presence of hypersensitivity to Lidocaine 9. History and/or presence of hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components of XIFAXAN 10. History and/or presence of hypersensitivity to acrylate or methacrylate, commonly used components of medical adhesives 11. Any other factor, condition, or disease, including, but not limited to, cardiovascular, respiratory, hematological, renal, hepatic, or gastrointestinal disorders that may, in the opinion of the Investigator, jeopardize the safety of the patient, alter drug absorption and pharmacokinetics or impact the validity of the study results. 12. Subjects with Type 1 Diabetes Mellitus (DM), diabetic ketoacidosis, with or without coma 13. Subjects with Glucose 6-phosphate dehydrogenase (G6PD) deficiency 14. History and/or presence of drug addiction or alcohol abuse within the past 12 months. 15. History of significant psychiatric or neurological illness, including seizure disorders. 16. Any medical or surgical conditions which might significantly interfere with the functions of gastrointestinal tract (e.g., gastric/intestinal bypass surgeries, fistulas, strictures, stenosis, or physiological/mechanical obstruction of the G.I tract, gastric bezoars, irritable bowel disease, crohn's disease, diverticulosis, or chronic narcotic use). 17. History of dysphagia to liquids, food, or pills 18. History of abdominal radiation therapy 19. Pregnant or lactating females 20. Any clinically significant abnormal lab values during screening in the opinion of the investigator. 21. Use of alcohol and/or nicotine containing products 48 hours prior to dosing visits, and throughout PK sampling visits. 22. Use of any medications and/or supplements, prescriptions or over the counter 1 week prior to beginning the study, and throughout the study except for birth control with approved methods of contraception when used consistently and correctly (Implants (i.e. Implanon, Nexplanon), Injectables (i.e. Depo-Provera), Combined, Oral Contraceptives, Intrauterine Devices (IUD's) (i.e. Mirena, ParaGard), and Sexual Abstinence are accepted). 23. Use of aspirin or any blood thinner medications. 24. Use of an implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump. 25. Volunteers unwilling or unable to take the proposed drugs or undergo G.I intubation 26. Enrollment in a clinical trial in the past 30 days 27. Current enrollment in a clinical trial with another study drug, vaccine or medical device 28. Fasting blood glucose level \< 80 mg/dL. 29. Inability or unwillingness to fast for 19 hours. 30. Blood donations in the past 8 weeks except for apheresis. 31. Volunteer shows a positive result of COVID-19 Antigen Rapid test in dosing visits 32. Volunteer is having any of the following symptoms: * Fever (over 100.4 oF or 38 oC) or feeling feverish * New cough * New shortness of breath 33. Volunteer is having two of any of these symptoms: * Chills * Muscle aches * New URI symptom(s) (runny nose, nasal congestion, and/or sore throat) * New loss of sense of smell or sense of taste * New headache 34. Volunteer has been in close contact in the last 14 days with someone recently diagnosed with COVID-19 35. Volunteer has returned from international travel within the past 10 days
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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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University of Michigan
Ann Arbor, Michigan, 48109, United States