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NCT05264493 · ClinicalTrials.gov registry record · Phase 1
Bioavailability Study of Naloxone 5 Milligrams (mg) Intramuscular (IM) Autoinjector
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT05264493: Completed Phase 1 study, sponsored by Pfizer.
NCT05264493 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05264493, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
To compare the plasma concentration (bioavailability) and safety of a single naloxone 5 mg autoinjector intramuscular (IM) injection to a single 2 mg IM injection (an approved safe dose) and to a single 2 mg bolus intravenous (IV) injection (an approved safe dose)
Primary Outcome
Comparison of bioavailability
Interventions
- DRUG NaxRedy ™
- DRUG Naloxone Hydrochloride Injection, USP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2020-10-06 |
| Est. Completion | 2021-01-08 |
| Phase | Phase 1 |
What the finished NCT05264493 record still lists
NCT05264493 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which NaxRedy ™ is the first listed.
NCT05264493 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05264493 about?
NCT05264493 is a clinical study titled "Bioavailability Study of Naloxone 5 Milligrams (mg) Intramuscular (IM) Autoinjector". To compare the plasma concentration (bioavailability) and safety of a single naloxone 5 mg autoinjector intramuscular (IM) injection to a single 2 mg IM injection (an approved safe dose) and to a single 2 mg bolus intravenous (IV) injection (an approved safe dose)
What is the current status of trial NCT05264493?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2020-10-06. Estimated completion is 2021-01-08.
What interventions are being tested in trial NCT05264493?
The interventions under investigation include: NaxRedy ™ (DRUG), Naloxone Hydrochloride Injection, USP (DRUG).
Who is sponsoring clinical trial NCT05264493?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05264493's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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