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NCT05796362 · ClinicalTrials.gov registry record · Phase 1
A Single-Dose, Three-Way, Three-Sequence, Crossover BA Study of Azithromycin Oleogel
A Phase 1 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT05796362: Completed Phase 1 study, sponsored by Brigham and Women's Hospital.
NCT05796362 is a Phase 1 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05796362, a Phase 1 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This is an exploratory study to describe the pharmacokinetics of the azithromycin oral and rectal oleogel in humans compared to the reference oral drug to (Zithromax) assess the impact of the novel formulation on bioavailability. The investigators will perform a randomized, balanced, single dose, three-treatment, three-period, crossover oral bioavailability study under fasted conditions to evaluate the safety and tolerability of azithromycin oleogel and compare the bioavailability of the azithromycin oleogel to the reference drug.
Primary Outcome
Azithromycin bioavailability of oral and rectal oleogels in healthy volunteers as measured by drug concentrations serum of study participants compared to reference standard bioavailability
Interventions
- DRUG Azithromycin Oleogel (Oral and Rectal)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2024-08-08 |
| Est. Completion | 2025-11-25 |
| Phase | Phase 1 |
What the finished NCT05796362 record still lists
NCT05796362 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which Azithromycin Oleogel (Oral and Rectal) is the first listed.
NCT05796362 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05796362 about?
NCT05796362 is a clinical study titled "A Single-Dose, Three-Way, Three-Sequence, Crossover BA Study of Azithromycin Oleogel". This is an exploratory study to describe the pharmacokinetics of the azithromycin oral and rectal oleogel in humans compared to the reference oral drug to (Zithromax) assess the impact of the novel formulation on bioavailability. The investigators will perform a randomized, balanced, single dose, th...
What is the current status of trial NCT05796362?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2024-08-08. Estimated completion is 2025-11-25.
What interventions are being tested in trial NCT05796362?
The interventions under investigation include: Azithromycin Oleogel (Oral and Rectal) (DRUG).
Who is sponsoring clinical trial NCT05796362?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05796362's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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