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NCT00647686 · ClinicalTrials.gov registry record · Phase 1

Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System With Askina Derm Overlay

A Phase 1 study, sponsored by Mylan Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
80
Enrollment target

NCT00647686 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 80 participants.

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The verdict

NCT00647686, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
80 participants
Enrollment target

Study Summary

The objective of this study was primarily to investigate the bioequivalence and secondly to assess the wearability (adhesion) and acute irritation of Mylan fentanyl transdermal system with and without an overlay system following a single 25 µg/hr application worn for 72 hours.

Interventions

  • DRUG Fentanyl Transdermal System 25 mcg/h + Askina Derm Overlay
  • DRUG Fentanyl Transdermal System 25 mcg/h

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2006-06
Est. Completion 2006-07
Phase Phase 1

Sponsor

Mylan Pharmaceuticals

146 total trials

What the Registry Record Tells You About NCT00647686

The ClinicalTrials.gov registry entry for NCT00647686 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Fentanyl Transdermal System 25 mcg/h + Askina Derm Overlay is the first listed.

NCT00647686 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00647686 about?

NCT00647686 is a clinical study titled "Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System With Askina Derm Overlay". The objective of this study was primarily to investigate the bioequivalence and secondly to assess the wearability (adhesion) and acute irritation of Mylan fentanyl transdermal system with and without an overlay system following a single 25 µg/hr application worn for 72 hours.

What is the current status of trial NCT00647686?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2006-06. Estimated completion is 2006-07.

What interventions are being tested in trial NCT00647686?

The interventions under investigation include: Fentanyl Transdermal System 25 mcg/h + Askina Derm Overlay (DRUG), Fentanyl Transdermal System 25 mcg/h (DRUG).

Who is sponsoring clinical trial NCT00647686?

This trial is sponsored by Mylan Pharmaceuticals, which has 146 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.