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NCT05159427 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study of Single-Dose Modified Release Glipizide in Healthy Volunteers
A Phase 1 study of Human Gastrointestinal Physiology Data, sponsored by University of Michigan.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05159427 is a Phase 1 study of Human Gastrointestinal Physiology Data that is actively recruiting participants, run by University of Michigan. The registered enrollment target is 40 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05159427, a Phase 1 study of Human Gastrointestinal Physiology Data, is actively recruiting participants, sponsored by University of Michigan.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- 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
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-03-15 |
| Est. Completion | 2026-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05159427
The ClinicalTrials.gov registry entry for NCT05159427 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Human Gastrointestinal Physiology Data appearing as the primary indexed condition, and to 4 interventions - of which Glucotrol XL 5Mg Extended-Release Tablet is the first listed.
NCT05159427 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT05159427 about?
NCT05159427 is a clinical study titled "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 intest...
What is the current status of trial NCT05159427?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2022-03-15. Estimated completion is 2026-09.
What conditions does trial NCT05159427 study?
This clinical trial studies the following conditions: Human Gastrointestinal Physiology Data.
What interventions are being tested in trial NCT05159427?
The interventions under investigation include: Glucotrol XL 5Mg Extended-Release Tablet (DRUG), Glipizide ER 5 MG 24 HR Extended Release Oral Tablet (DRUG), Rifaximin 200Mg Tab (DRUG), 13C6-Glipizide (DRUG).
Who is sponsoring clinical trial NCT05159427?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05159427 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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