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Modified Release Glipizide for Gastrointestinal Absorption Study

Phase 1
Recruiting
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
New shortness of breath
New loss of sense of smell or sense of taste
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time 0 to (72 up to 168) hours
Awards & highlights

Study Summary

This trial will help to understand how well a drug dissolves and is absorbed in the gastrointestinal tract.

Who is the study for?
Healthy adults aged 18-55 with a BMI of 18.5 to 35 kg/m2 who can swallow a pill similar to SmartPill and provide informed consent are eligible for this trial. Exclusions include those with recent surgeries, hypersensitivities, diabetes, abnormal lab values, dysphagia, substance use before visits, certain medication usage including blood thinners and electro-mechanical medical devices.Check my eligibility
What is being tested?
The study tests how well different modified release forms of Glipizide dissolve in the GI tract and get absorbed into the body by sampling stomach/intestinal contents and bodily fluids. It also collects data on GI physiology using an electronic pill called SmartPill.See study design
What are the potential side effects?
Potential side effects may include reactions related to drug sensitivities such as allergies to rifaximin or sulfonamide derivatives mentioned in the exclusion criteria but specific side effects are not listed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have recently started feeling short of breath.
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I have recently lost my sense of smell or taste.
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I can understand and agree to the study details on my own.
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I can swallow a pill the size of a multivitamin.
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I have new symptoms like a runny nose, nasal congestion, or sore throat.
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I have recently developed a cough.
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I have had a fever or felt feverish recently.
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I have recently started experiencing headaches.
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I am between 18 and 55 years old with a BMI between 18.5 and 35.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time 0 to (72 up to 168) hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time 0 to (72 up to 168) hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average Area Under the Plasma Concentration-time Curve to infinite time (AUCinfinity) of Glipizide After a Single Dose of Glipizide with and without Gastrointestinal Intubation and between Two Modified Release Glipizide formulations
Secondary outcome measures
Gastric Emptying (GE) Time after Oral Administration of Modified Release Formulation of Glipizide
Gastrointestinal pH after Oral Administration of Modified Release Formulation of Glipizide
Gastrointestinal pressure after Oral Administration of Modified Release Formulation of Glipizide
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: SmartPill®Experimental Treatment4 Interventions
Single dose of Glipizide (5 mg modified-release tablet), Rifaximin (200 mg tablet) and SmartPill® administered with 200 mL of 14% glucose solution in water + 1 mg of the stable isotope Glipizide (13C6-Glipizide) with 40 ml of 14% glucose solution in water.
Group II: G.I IntubationExperimental Treatment4 Interventions
Single dose of Glipizide (5 mg modified-release tablet) and Rifaximin (200 mg tablet) administered with 200 mL of 14% glucose solution in water + 1 mg of the stable isotope Glipizide (13C6-Glipizide) with 40 ml of 14% glucose solution in water. A 'Stable isotope' means a heavier version of the drug that is not radioactive.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of MichiganLead Sponsor
1,797 Previous Clinical Trials
6,378,018 Total Patients Enrolled
1 Trials studying Human Gastrointestinal Physiology Data
48 Patients Enrolled for Human Gastrointestinal Physiology Data
Food and Drug Administration (FDA)FED
171 Previous Clinical Trials
1,331,566 Total Patients Enrolled
1 Trials studying Human Gastrointestinal Physiology Data
48 Patients Enrolled for Human Gastrointestinal Physiology Data

Media Library

13C6-Glipizide Clinical Trial Eligibility Overview. Trial Name: NCT05159427 — Phase 1
Human Gastrointestinal Physiology Data Research Study Groups: G.I Intubation, SmartPill®
Human Gastrointestinal Physiology Data Clinical Trial 2023: 13C6-Glipizide Highlights & Side Effects. Trial Name: NCT05159427 — Phase 1
13C6-Glipizide 2023 Treatment Timeline for Medical Study. Trial Name: NCT05159427 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this experiment begun recruiting participants yet?

"According to clinicaltrials.gov, this experiment is actively recruiting patients at the current moment in time. It was first announced on March 15th 2022 and has been edited as recently as March 19th 2022."

Answered by AI

Are there any negative health implications to using 13C6-Glipizide?

"Due to the limited evidence concerning efficacy and safety, 13C6-Glipizide received a score of 1 on our team's scale."

Answered by AI

Is it feasible for me to join this clinical trial?

"In order to meet the requirements of this study, potential candidates must possess knowledge on human gastrointestinal physiology and are within the ages 18-55. The research team is looking for 40 individuals total."

Answered by AI

Are octogenarians eligible for enrollment in this investigation?

"This clinical trial seeks out individuals in the 18-55 age range to participate."

Answered by AI

What conditions can 13C6-Glipizide be employed to address?

"13C6-Glipizide is an efficacious treatment for various illnesses, such as irritable bowel syndrome (IBS), hepatic encephalopathy, and bacterial infections."

Answered by AI

How many participants are currently signed up for this clinical trial?

"Affirmative. According to the information hosted on clinicaltrials.gov, this experiment is actively searching for participants. It was initially posted on 15th of March 2022 and the most recent update occurred four days later - 19th of March 2022. 40 people need to be enrolled at a single medical centre in order to conclude the study's activities successfully."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pharmacokinetic Study of Single-Dose Modified Release Glipizide in Healthy Volunteers
Duxin Sun 2022. "Pharmacokinetic Study of Single-Dose Modified Release Glipizide in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05159427.
~14 spots leftby Jul 2025
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