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NCT03827629 · ClinicalTrials.gov registry record · Phase 1
A Study to Compare Bioavailability of Naloxone Nasal Spray and Naloxone Hydrochloride (HCl) Intramuscular Injection (IM) in Healthy Volunteers
A Phase 1 study of Healthy Volunteer, sponsored by INSYS Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT03827629: Completed Phase 1 study of Healthy Volunteer, sponsored by INSYS Therapeutics.
NCT03827629 is a Phase 1 study of Healthy Volunteer that has completed, run by INSYS Therapeutics. The registered enrollment target is 24 participants, below the 202-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03827629, a Phase 1 study of Healthy Volunteer, has completed, sponsored by INSYS Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
The main objective of this study is to compare early exposures of two test formulations of Naloxone Nasal Spray with the reference formulation of Naloxone HCl IM Injection under fasted conditions.
Conditions Studied
Interventions
- DRUG Treatment A: Naloxone Nasal Spray
- DRUG Treatment B: Naloxone Nasal Spray
- DRUG Treatment C: Naloxone HCL Intramuscular (IM) Injection
Study Locations (1)
Texas
- Worldwide Clinical Trials - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-08-07 |
| Est. Completion | 2017-08-16 |
| Phase | Phase 1 |
What the finished NCT03827629 record still lists
NCT03827629 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 202-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 3 interventions - of which Treatment A: Naloxone Nasal Spray is the first listed.
NCT03827629 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03827629 about?
NCT03827629 is a clinical study titled "A Study to Compare Bioavailability of Naloxone Nasal Spray and Naloxone Hydrochloride (HCl) Intramuscular Injection (IM) in Healthy Volunteers". The main objective of this study is to compare early exposures of two test formulations of Naloxone Nasal Spray with the reference formulation of Naloxone HCl IM Injection under fasted conditions.
What is the current status of trial NCT03827629?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2017-08-07. Estimated completion is 2017-08-16.
What conditions does trial NCT03827629 study?
This clinical trial studies the following conditions: Healthy Volunteer.
What interventions are being tested in trial NCT03827629?
The interventions under investigation include: Treatment A: Naloxone Nasal Spray (DRUG), Treatment B: Naloxone Nasal Spray (DRUG), Treatment C: Naloxone HCL Intramuscular (IM) Injection (DRUG).
Who is sponsoring clinical trial NCT03827629?
This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03827629 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Volunteer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03827629's enrollment target sits among peer trials
24 85th of 112 higher than 20 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer 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.
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