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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 is a Phase 1 study that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 30 participants.
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.
Interventions
- DRUG Naloxone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-10 |
| Est. Completion | 2015-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02572089
The ClinicalTrials.gov registry entry for NCT02572089 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Drug Abuse (NIDA), which has 335 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Naloxone is the first listed.
NCT02572089 reports 0 study locations.
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.
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