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RECRUITING
NCT05159427
PHASE1

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

Sponsor: University of Michigan

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2022-03-15

Completion Date

2026-09

Last Updated

2026-03-17

Healthy Volunteers

Yes

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.

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States