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

NCT05159427 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-17

No results posted yet for this study

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 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

  • Human Gastrointestinal Physiology Data

Interventions

DRUG

Glucotrol XL 5Mg Extended-Release Tablet

Participants are randomized to take one tablet of this study drug by mouth.

DRUG

Glipizide ER 5 MG 24 HR Extended Release Oral Tablet

Participants are randomized to take one tablet of this study drug by mouth.

DRUG

Rifaximin 200Mg Tab

Participants will take one tablet of this study drug by mouth.

DRUG

13C6-Glipizide

Participants will take 1 mg of this study drug dissolved in 40 ml glucose solution by mouth.

Sponsors & Collaborators

Principal Investigators

  • Cathrin Ring · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-15
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05159427 on ClinicalTrials.gov