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NCT03827642 · ClinicalTrials.gov registry record · Phase 1
A Study to Compare Bioavailability of Naloxone Nasal Spray, Naloxone Hydrochloride (HCl) Intravenous (IV) and Intramuscular Injection (IM) in Healthy Volunteers
A Phase 1 study, sponsored by INSYS Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT03827642 is a Phase 1 study that has completed, run by INSYS Therapeutics. The registered enrollment target is 24 participants.
The verdict
NCT03827642, a Phase 1 study, has completed, sponsored by INSYS Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The main objective of this study was to compare the bioavailability of two test formulations of Naloxone Nasal Spray with the reference formulations of Naloxone HCl IV and IM injection under fasted conditions.
Interventions
- DRUG Treatment A: Naloxone Nasal Spray
- DRUG Treatment B: Naloxone Nasal Spray
- DRUG Treatment C: Naloxone HCl Intravenous (IV) Injection
- DRUG Treatment D: Naloxone HCl Intramuscular (IM) Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-04-23 |
| Est. Completion | 2018-05-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03827642
The ClinicalTrials.gov registry entry for NCT03827642 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is INSYS Therapeutics, which has 35 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Treatment A: Naloxone Nasal Spray is the first listed.
NCT03827642 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03827642 about?
NCT03827642 is a clinical study titled "A Study to Compare Bioavailability of Naloxone Nasal Spray, Naloxone Hydrochloride (HCl) Intravenous (IV) and Intramuscular Injection (IM) in Healthy Volunteers". The main objective of this study was to compare the bioavailability of two test formulations of Naloxone Nasal Spray with the reference formulations of Naloxone HCl IV and IM injection under fasted conditions.
What is the current status of trial NCT03827642?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2018-04-23. Estimated completion is 2018-05-06.
What interventions are being tested in trial NCT03827642?
The interventions under investigation include: Treatment A: Naloxone Nasal Spray (DRUG), Treatment B: Naloxone Nasal Spray (DRUG), Treatment C: Naloxone HCl Intravenous (IV) Injection (DRUG), Treatment D: Naloxone HCl Intramuscular (IM) Injection (DRUG).
Who is sponsoring clinical trial NCT03827642?
This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.
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