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drugset / Trial / NCT05159427

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

NCT05159427 ↗

Phase 1 Completed 30 enrolled University of Michigan Food and Drug Administration (FDA) · collab
RandomizedParallel-groupOpen-labelBasic science

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.

Timeline

Start
2022-03-15
Primary completion
2026-03-24
Completion
2026-03-29

Drugs

EvaluationDrugModalityDoseRoute
Subject 13C6-Glipizide Unknown 1 mg Oral
Subject Glipizide Small molecule 5 mg Oral
Background Rifaximin Other / unclassified 200 mg Oral

Indications

No indication recorded.