Actively Recruiting
Pharmacokinetic Study of Single-Dose Modified Release Glipizide in Healthy Volunteers
Led by University of Michigan · Updated on 2026-03-17
40
Participants Needed
1
Research Sites
233 weeks
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
F
Food and Drug Administration (FDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pharmacokinetic Study of Single-Dose Modified Release Glipizide in Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Unable to independently provide an informed consent or mentally incapacitated
- Physical disability requiring special arrangements
- Significant clinical illness including cardiovascular, neurological disease, organ failure, or malignancy
- Surgical procedure within 3 weeks prior to screening
- Severe seasonal allergies or severe allergic diseases including drug, food, or SmartPill device allergies
- Hypersensitivity to any study drugs or their components including sulfonamide derivatives, lidocaine, rifaximin, rifamycin antimicrobial agents, acrylate or methacrylate adhesives
- Any condition that may jeopardize safety, affect drug absorption or study validity
- Type 1 Diabetes Mellitus, diabetic ketoacidosis
- Glucose 6-phosphate dehydrogenase deficiency
- Drug addiction or alcohol abuse within past 12 months
- Significant psychiatric or neurological illness including seizures
- Medical or surgical conditions affecting gastrointestinal tract function
- History of difficulty swallowing liquids, food, or pills
- History of abdominal radiation therapy
- Pregnant or lactating females
- Clinically significant abnormal lab values during screening
- Use of alcohol or nicotine products 48 hours prior to dosing and during sampling
- Use of medications or supplements one week prior and during study except approved birth control
- Use of aspirin or blood thinners
- Use of implanted or portable electro-mechanical medical devices
- Unwillingness to take study drugs or undergo gastrointestinal intubation
- Enrollment in another clinical trial within past 30 days
- Fasting blood glucose level less than 80 mg/dL
- Inability or unwillingness to fast for 19 hours
- Blood donations in past 8 weeks except apheresis
- Positive COVID-19 test or symptoms at dosing visits
- Close contact with COVID-19 cases within last 14 days
- International travel within past 10 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
C
Cathrin Ring
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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