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NCT02138396 · ClinicalTrials.gov registry record · NA

Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting Conditions

A NA study, sponsored by INSYS Therapeutics.

Completed
Registry status
NA
Development phase
12
Enrollment target

NCT02138396: Completed NA study, sponsored by INSYS Therapeutics.

NCT02138396 is a NA study that has completed, run by INSYS Therapeutics. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02138396, a NA study, has completed, sponsored by INSYS Therapeutics.

COMPLETED
Registry status
NA
Development phase
12 participants
Enrollment target

Study Summary

The objective of this study is to compare the rate of absorption and bioavailability of fentanyl sublingual spray 400 mcg to fentanyl citrate 100 mcg by intramuscular injection.

Interventions

  • DRUG Naltrexone
  • DRUG Fentanyl Sublingual Spray (FSS)
  • DRUG Fentanyl Citrate Injection (FCI)

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2014-01
Est. Completion 2014-01
Phase NA
INSYS Therapeutics

35 total trials

What the finished NCT02138396 record still lists

NCT02138396 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 3 interventions - of which Naltrexone is the first listed.

NCT02138396 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02138396 about?

NCT02138396 is a clinical study titled "Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting Conditions". The objective of this study is to compare the rate of absorption and bioavailability of fentanyl sublingual spray 400 mcg to fentanyl citrate 100 mcg by intramuscular injection.

What is the current status of trial NCT02138396?

This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2014-01. Estimated completion is 2014-01.

What interventions are being tested in trial NCT02138396?

The interventions under investigation include: Naltrexone (DRUG), Fentanyl Sublingual Spray (FSS) (DRUG), Fentanyl Citrate Injection (FCI) (DRUG).

Who is sponsoring clinical trial NCT02138396?

This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02138396's enrollment target sits among peer trials

12 1913th of 2000 higher than 74 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT02138396, the US trial registry maintained by the National Library of Medicine. NCT02138396 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.