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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

Must not have

History of abdominal radiation therapy

Any surgical procedure within 3 weeks prior to screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from time 0 to 78 hours

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation therapy to my abdomen.

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I have not had surgery in the last 3 weeks.

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I am willing and able to take the proposed drugs and undergo G.I intubation.

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I am taking aspirin or blood thinners.

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I need special arrangements due to a physical disability.

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I am unable to understand or sign the consent form by myself due to mental incapacity.

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I have trouble swallowing liquids, food, or pills.

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I have Type 1 Diabetes and have experienced diabetic ketoacidosis.

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I have G6PD deficiency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time 0 to 78 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from time 0 to 78 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time 0 to 78 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Gastrointestinal pH after Oral Administration of Modified Release Formulation of Glipizide

Maximum Gastrointestinal fluid concentration of Glipizide after Oral Administration of a Single Dose Modified Released Formulation of Glipizide

Plasma Cmax of Glipizide After a Single Dose of Glipizide with and without Gastrointestinal Intubation and between Two Modified Release Glipizide formulations

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: No G.I IntubationExperimental Treatment4 Interventions

Single dose of Glipizide (5 mg modified-release tablet) and Rifaximin (200 mg tablet) administered with 200 mL of 20% 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

0 / 18Eligibility criteria met