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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: Recruiting Phase 1 study of Human Gastrointestinal Physiology Data, sponsored by University of Michigan.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Average Area Under the Plasma Concentration-time Curve to infinite time (AUCinfinity) of Glipizide will be measured at multiple timepoints over a 78 hour period at each of the two study phases
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 |
What NCT05159427 shows while recruiting
NCT05159427 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05159427's enrollment target sits among peer trials
40 1131st of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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