Pharmacokinetic Study of Single-Dose Modified Release Glipizide in Healthy Volunteers

Completed · Phase 1

Conditions studied: Human Gastrointestinal Physiology Data

In brief

In vivo drug dissolution in the gastrointestinal (GI) tract is largely unmeasured. The purpose of this clinical study is to evaluate the in vivo drug dissolution and systemic absorption of modified release formulations of the BCS Class II drug Glipizide by direct sampling of stomach and small intestinal luminal content, blood, urine and feces. Expanding current knowledge of drug dissolution in vivo will help to establish physiologically relevant in vitro models predictive of drug dissolution.

Key facts

Study ID

NCT05159427

Run by

University of Michigan

People needed

30

Starts

2022-03-15

Expected to finish

2026-03-29

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female adults age 18 to 55 years with BMI ranging from 18.5 to 35 kg/m2 inclusive
• Ability to independently provide an informed consent
• Demonstrate the ability to swallow a multivitamin pill that mimics a SmartPill capsule
• Negative serum pregnancy test (for women of child-bearing potential)

You may not qualify if…

• Unable to independently provide an informed consent for themselves or mentally incapacitated.
• Physical disability (including blindness or deafness) that requires special arrangements.
• Significant clinical illness, including cardiovascular disease, neurological disease, organ failure, or malignancy in the opinion of the investigator
• Any surgical procedure within 3 weeks prior to screening
• History and/or presence of severe seasonal allergies or severe allergic diseases including drug allergies, food allergies and allergy against the SmartPill® device
• History and/or presence of hypersensitivity to any of the study drugs or the products' excipients
• History and/or presence of hypersensitivity to Sulfonamide derivatives
• History and/or presence of hypersensitivity to Lidocaine
• History and/or presence of hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components of XIFAXAN
• History and/or presence of hypersensitivity to acrylate or methacrylate, commonly used components of medical adhesives
• 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.
• Subjects with Type 1 Diabetes Mellitus (DM), diabetic ketoacidosis, with or without coma
• Subjects with Glucose 6-phosphate dehydrogenase (G6PD) deficiency
• History and/or presence of drug addiction or alcohol abuse within the past 12 months.
• History of significant psychiatric or neurological illness, including seizure disorders.
• 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).
• History of dysphagia to liquids, food, or pills
• History of abdominal radiation therapy
• Pregnant or lactating females
• Any clinically significant abnormal lab values during screening in the opinion of the investigator.
• Use of alcohol and/or nicotine containing products 48 hours prior to dosing visits, and throughout PK sampling visits.
• 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).
• Use of aspirin or any blood thinner medications.
• Use of an implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump.
• Volunteers unwilling or unable to take the proposed drugs or undergo G.I intubation

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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