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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 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 13 participants.
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)
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05264493
The ClinicalTrials.gov registry entry for NCT05264493 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which NaxRedy ™ is the first listed.
NCT05264493 reports 0 study locations.
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.
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