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NCT02572089 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers
A Phase 1 study, sponsored by National Institute on Drug Abuse (NIDA).
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT02572089: Completed Phase 1 study, sponsored by National Institute on Drug Abuse (NIDA).
NCT02572089 is a Phase 1 study that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02572089, a Phase 1 study, has completed, sponsored by National Institute on Drug Abuse (NIDA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
To determine the pharmacokinetics of 4 intranasal doses of naloxone compared to a 0.4 mg dose of naloxone administrated intramuscular and to identify an appropriate intranasal dose that could achieve systemic exposure comparable to an approved parenteral dose. To also determine the pharmacokinetics of two different concentrations of intranasal naloxone and finally, to determine the safety of intranasal naloxone with respect to nasal irritation.
Primary Outcome
Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration.
Interventions
- DRUG Naloxone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-10 |
| Est. Completion | 2015-01 |
| Phase | Phase 1 |
What the finished NCT02572089 record still lists
NCT02572089 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which Naloxone is the first listed.
NCT02572089 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02572089 about?
NCT02572089 is a clinical study titled "Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers". To determine the pharmacokinetics of 4 intranasal doses of naloxone compared to a 0.4 mg dose of naloxone administrated intramuscular and to identify an appropriate intranasal dose that could achieve systemic exposure comparable to an approved parenteral dose. To also determine the pharmacokinetics ...
What is the current status of trial NCT02572089?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2014-10. Estimated completion is 2015-01.
What interventions are being tested in trial NCT02572089?
The interventions under investigation include: Naloxone (DRUG).
Who is sponsoring clinical trial NCT02572089?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02572089's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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