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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.

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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

FieldValue
Enrollment Target 24 participants
Start Date 2018-04-23
Est. Completion 2018-05-06
Phase Phase 1

Sponsor

INSYS Therapeutics

35 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.