Human Gastrointestinal Physiology DataPhase 1NCT05159427
Pharmacokinetic Study of Single-Dose Modified Release Glipizide in Healthy Volunteers
A Phase 1 study testing Glucotrol XL 5Mg Extended-Release Tablet, Glipizide ER 5 MG 24 HR Extended Release Oral Tablet and Rifaximin 200Mg Tab in people with Human Gastrointestinal Physiology Data, run by University of Michigan at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Gastrointestinal Physiology Data
- What is being tested?
- Glucotrol XL 5Mg Extended-Release Tablet, Glipizide ER 5 MG 24 HR Extended Release Oral Tablet and Rifaximin 200Mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2022to 29 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 43Show fewer
- 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
- Enrollment in a clinical trial in the past 30 days
- Current enrollment in a clinical trial with another study drug, vaccine or medical device
- Fasting blood glucose level < 80 mg/dL.
- Inability or unwillingness to fast for 19 hours.
- Blood donations in the past 8 weeks except for apheresis.
- Volunteer shows a positive result of COVID-19 Antigen Rapid test in dosing visits
- 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
- 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
- Volunteer has been in close contact in the last 14 days with someone recently diagnosed with COVID-19
- Volunteer has returned from international travel within the past 10 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label, Randomized, Pharmacokinetic Study of Single-Dose Modified Release Glipizide in Healthy Volunteers
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.
Read the detailed description
This is an in vivo study designed to acquire human gastrointestinal (GI) physiology data from healthy subjects which are necessary for mechanistic absorption model development. Each subject will be asked to complete a single dosing phase. The dosing phase will include collection of fluids from stomach and gastrointestinal (GI) tract through intubation (putting a GI tube from mouth into stomach and intestines), blood, urine and feces, and measure glipizide concentrations.
The objectives of this study are, as follows: Objective #1: To characterize the plasma, gastrointestinal fluid, urine, and feces concentrations of glipizide after oral administration of modified release formulations; Objective #2: To compare the pharmacokinetics of glipizide between the two modified release formulations; Objective #3: To collect gastrointestinal physiology data in volunteers receiving an oral MR formulation of glipizide. These in vivo results will be used to validate in vitro dissolution methods and to support computational and mathematical modeling efforts, in order to develop an oral drug product optimization process that may be applied to future drugs to maximize oral drug safety and efficacy.
- Conditions
- Human Gastrointestinal Physiology Data
- Being tested
- Glucotrol XL 5Mg Extended-Release Tablet, Glipizide ER 5 MG 24 HR Extended Release Oral Tablet, Rifaximin 200Mg Tab, 13C6-Glipizide
- Keywords
- Clinical study, Glipizide, Modified release, Pharmacokinetics, In vivo dissolution, Local gastrointestinal concentration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucotrol XL 5Mg Extended-Release TabletDrug
Participants are randomized to take one tablet of this study drug by mouth.
Glipizide ER 5 MG 24 HR Extended Release Oral TabletDrug
Participants are randomized to take one tablet of this study drug by mouth.
Rifaximin 200Mg TabDrug
Participants will take one tablet of this study drug by mouth.
13C6-GlipizideDrug
Also called Stable Isotope Glipizide
Participants will take 1 mg of this study drug dissolved in 40 ml glucose solution by mouth.
| Study group | Role | What they receive |
|---|---|---|
| G.I Intubation | Experimental | 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. A 'Stable isotope' means a heavier version of the drug that is not radioactive. Receives: Drug: Glucotrol XL 5Mg Extended-Release Tablet; Drug: Glipizide ER 5 MG 24 HR Extended Release Oral Tablet; Drug: Rifaximin 200Mg Tab; Drug: 13C6-Glipizide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Area Under the Plasma Concentration-time Curve to infinite time (AUCinfinity) of Glipizide After a Single Dose of Glipizide with Gastrointestinal Intubation and between Two Modified Release Glipizide formulations
Average Area Under the Plasma Concentration-time Curve to infinite time (AUCinfinity) of Glipizide will be measured at multiple timepoints over a 78 hour period at each of the two study phases
Measured: From time 0 to 78 hours
Secondary outcomes (5)
Plasma Cmax of Glipizide After a Single Dose of Glipizide with Gastrointestinal Intubation and between Two Modified Release Glipizide formulations
Peak Plasma Concentration of Glipizide (Cmax) will be measured at multiple timepoints over a 78 hour period at the study phase
Measured: From time 0 to 78 hours
Plasma Tmax of Glipizide After a Single Dose of Glipizide with Gastrointestinal Intubation and between Two Modified Release Glipizide formulations
The time it takes to reach the maximum concentration of Glipizide in Plasma (Tmax) will be measured at multiple timepoints over a 78 hour period at the study phase
Measured: From time 0 to 78 hours
Urine and Feces concentrations of Glipizide After a Single Dose of Glipizide with Gastrointestinal Intubation and between Two Modified Release Glipizide formulations
Recovery of Glipizide in urine and feces will be measured at multiple timepoints over a 78 hour period at the study phase
Measured: From time 0 to 78 hours
Maximum Gastrointestinal fluid concentration of Glipizide after Oral Administration of a Single Dose Modified Released Formulation of Glipizide
The concentration of Glipizide in gastrointestinal fluid (stomach, duodenum, jejunum and ileum) will be measured at multiple timepoints over a 7 hour period using a 4-port G.I Intubation Catheter
Measured: From time 0 to 7 hours
Gastrointestinal pH after Oral Administration of Modified Release Formulation of Glipizide
Gastrointestinal pH will be measured ex-vivo in gastrointestinal fluid samples collected through gastrointestinal intubation catheter over a duration of 7 hours.
Measured: From time 0 to 7 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start15 Mar 2022
- Primary completion24 Mar 2026
- Study completion29 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Gastrointestinal Physiology DataStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel study design. Subjects are asked to complete the study events/procedures in one phases (G.I intubation) with one of the two formulations of glipizide.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Principal investigator, Duxin Sun, University of Michigan
- Investigators
- Cathrin Ring, Study director, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159427
- Sponsor's protocol ID
- HUM00199603
- Status last verified
- Jul 2026
- First submitted
- 17 Nov 2021
- Last updated
- 20 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Randomized, Pharmacokinetic Study of Single-Dose Modified Release Glipizide in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05159427
- Acronym / sponsor ID
- HUM00199603
- Conditions
- Human Gastrointestinal Physiology Data
- Keywords
- Clinical study, Glipizide, Modified release, Pharmacokinetics, In vivo dissolution, Local gastrointestinal concentration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 24 Mar 2026 (actual)
- Study completion
- 29 Mar 2026 (actual)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an in vivo study designed to acquire human gastrointestinal (GI) physiology data from healthy subjects which are necessary for mechanistic absorption model development. Each subject will be asked to complete a single dosing phase. The dosing phase will include collection of fluids from stomach and gastrointestinal (GI) tract through intubation (putting a GI tube from mouth into stomach and intestines), blood, urine and feces, and measure glipizide concentrations.
The objectives of this study are, as follows: Objective #1: To characterize the plasma, gastrointestinal fluid, urine, and feces concentrations of glipizide after oral administration of modified release formulations; Objective #2: To compare the pharmacokinetics of glipizide between the two modified release formulations; Objective #3: To collect gastrointestinal physiology data in volunteers receiving an oral MR formulation of glipizide. These in vivo results will be used to validate in vitro dissolution methods and to support computational and mathematical modeling efforts, in order to develop an oral drug product optimization process that may be applied to future drugs to maximize oral drug safety and efficacy.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a parallel study design. Subjects are asked to complete the study events/procedures in one phases (G.I intubation) with one of the two formulations of glipizide.
| Arm | Type | Receives |
|---|---|---|
| G.I Intubation | Experimental | Drug: Glucotrol XL 5Mg Extended-Release Tablet, Drug: Glipizide ER 5 MG 24 HR Extended Release Oral Tablet, Drug: Rifaximin 200Mg Tab, Drug: 13C6-GlipizideSingle 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. A 'Stable isotope' means a heavier version of the drug that is not radioactive. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (43 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucotrol XL 5Mg Extended-Release TabletParticipants are randomized to take one tablet of this study drug by mouth. | Drug | G.I Intubation |
| Glipizide ER 5 MG 24 HR Extended Release Oral TabletParticipants are randomized to take one tablet of this study drug by mouth. | Drug | G.I Intubation |
| Rifaximin 200Mg TabParticipants will take one tablet of this study drug by mouth. | Drug | G.I Intubation |
| 13C6-GlipizideAlso: Stable Isotope GlipizideParticipants will take 1 mg of this study drug dissolved in 40 ml glucose solution by mouth. | Drug | G.I Intubation |
Primary outcome
Average Area Under the Plasma Concentration-time Curve to infinite time (AUCinfinity) of Glipizide After a Single Dose of Glipizide with Gastrointestinal Intubation and between Two Modified Release Glipizide formulations
Time frame: From time 0 to 78 hours
Average Area Under the Plasma Concentration-time Curve to infinite time (AUCinfinity) of Glipizide will be measured at multiple timepoints over a 78 hour period at each of the two study phases
5 secondary outcomes
Plasma Cmax of Glipizide After a Single Dose of Glipizide with Gastrointestinal Intubation and between Two Modified Release Glipizide formulations
Time frame: From time 0 to 78 hours
Plasma Tmax of Glipizide After a Single Dose of Glipizide with Gastrointestinal Intubation and between Two Modified Release Glipizide formulations
Time frame: From time 0 to 78 hours
Urine and Feces concentrations of Glipizide After a Single Dose of Glipizide with Gastrointestinal Intubation and between Two Modified Release Glipizide formulations
Time frame: From time 0 to 78 hours
Maximum Gastrointestinal fluid concentration of Glipizide after Oral Administration of a Single Dose Modified Released Formulation of Glipizide
Time frame: From time 0 to 7 hours
Gastrointestinal pH after Oral Administration of Modified Release Formulation of Glipizide
Time frame: From time 0 to 7 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathrin Ring study director
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glucotrol XL 5Mg Extended-Release Tablet, Glipizide ER 5 MG 24 HR Extended Release Oral Tablet and Rifaximin 200Mg Tab in people with Human Gastrointestinal Physiology Data, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Area Under the Plasma Concentration-time Curve to infinite time (AUCinfinity) of Glipizide After a Single Dose of Glipizide with Gastrointestinal Intubation and between Two Modified Release Glipizide formulations (time frame: From time 0 to 78 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.