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NCT01780233 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetic Study of Fentanyl 400 µg Sublingual Spray, Actiq® 400 µg Transmucosally, and Fentanyl Citrate Injection 100 µg Intravenously (iv)

A Phase 1 study, sponsored by INSYS Therapeutics.

Completed
Registry status
Phase 1
Development phase
40
Enrollment target

NCT01780233: Completed Phase 1 study, sponsored by INSYS Therapeutics.

NCT01780233 is a Phase 1 study that has completed, run by INSYS Therapeutics. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01780233, a Phase 1 study, has completed, sponsored by INSYS Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target

Study Summary

The objective of this study was to compare the rate of absorption and bioavailability of fentanyl 400 µg sublingual spray, Actiq® 400 µg transmucosally, and fentanyl citrate injection 100 µg intravenously.

Interventions

  • DRUG Fentanyl 400 µg sublingual spray
  • DRUG Actiq® 400 µg transmucosally
  • DRUG Fentanyl citrate injection 100 µg intravenously
  • DRUG Naltrexone 50 mg

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2007-04
Est. Completion 2007-05
Phase Phase 1
INSYS Therapeutics

35 total trials

What the finished NCT01780233 record still lists

NCT01780233 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).

The record links to 0 conditions, and to 4 interventions - of which Fentanyl 400 µg sublingual spray is the first listed.

NCT01780233 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01780233 about?

NCT01780233 is a clinical study titled "Pharmacokinetic Study of Fentanyl 400 µg Sublingual Spray, Actiq® 400 µg Transmucosally, and Fentanyl Citrate Injection 100 µg Intravenously (iv)". The objective of this study was to compare the rate of absorption and bioavailability of fentanyl 400 µg sublingual spray, Actiq® 400 µg transmucosally, and fentanyl citrate injection 100 µg intravenously.

What is the current status of trial NCT01780233?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2007-04. Estimated completion is 2007-05.

What interventions are being tested in trial NCT01780233?

The interventions under investigation include: Fentanyl 400 µg sublingual spray (DRUG), Actiq® 400 µg transmucosally (DRUG), Fentanyl citrate injection 100 µg intravenously (DRUG), Naltrexone 50 mg (DRUG).

Who is sponsoring clinical trial NCT01780233?

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 NCT01780233's enrollment target sits among peer trials

40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT01780233, the US trial registry maintained by the National Library of Medicine. NCT01780233 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.