NCT05159427

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

Open-Label, Randomized, Pharmacokinetic Study of Single-Dose Modified Release Glipizide in Healthy Volunteers

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-15
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2021-12-16
• Last updated: 2026-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study