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NCT01173627 · ClinicalTrials.gov registry record · Phase 1

Bioequivalence of a Test Troche Formulation of Fentanyl Citrate (400 mcg) Compared to Actiq® 400 mcg, Cephalon, Inc.

A Phase 1 study, sponsored by Mallinckrodt.

Completed
Registry status
Phase 1
Development phase
50
Enrollment target

NCT01173627 is a Phase 1 study that has completed, run by Mallinckrodt. The registered enrollment target is 50 participants.

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The verdict

NCT01173627, a Phase 1 study, has completed, sponsored by Mallinckrodt.

COMPLETED
Registry status
Phase 1
Development phase
50 participants
Enrollment target

Study Summary

The purpose of this study was to evaluate the oral bioequivalence of the Mallinckrodt test fentanyl citrate oral transmucosal 400 mcg troche compared to Actiq 400 mcg (Cephalon, Inc.) under fasting conditions.

Interventions

  • DRUG Test fentanyl citrate 400 mcg troche
  • DRUG Actiq 400 mcg

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2006-08
Est. Completion 2006-08
Phase Phase 1

Sponsor

Mallinckrodt

69 total trials

What the Registry Record Tells You About NCT01173627

The ClinicalTrials.gov registry entry for NCT01173627 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mallinckrodt, which has 69 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Test fentanyl citrate 400 mcg troche is the first listed.

NCT01173627 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01173627 about?

NCT01173627 is a clinical study titled "Bioequivalence of a Test Troche Formulation of Fentanyl Citrate (400 mcg) Compared to Actiq® 400 mcg, Cephalon, Inc.". The purpose of this study was to evaluate the oral bioequivalence of the Mallinckrodt test fentanyl citrate oral transmucosal 400 mcg troche compared to Actiq 400 mcg (Cephalon, Inc.) under fasting conditions.

What is the current status of trial NCT01173627?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2006-08. Estimated completion is 2006-08.

What interventions are being tested in trial NCT01173627?

The interventions under investigation include: Test fentanyl citrate 400 mcg troche (DRUG), Actiq 400 mcg (DRUG).

Who is sponsoring clinical trial NCT01173627?

This trial is sponsored by Mallinckrodt, which has 69 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.