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NCT00650117 · ClinicalTrials.gov registry record · Phase 1

Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System

A Phase 1 study, sponsored by Mylan Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
12
Enrollment target

NCT00650117: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.

NCT00650117 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00650117, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study Summary

The objective of this study was to investigate the effect of three different types of occlusive overlays on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Mylan Pharmaceuticals Inc. by Mylan Technologies Inc., and Duragesic, 25 mcg/h manufactured for Janssen Pharmaceutica by ALZA Corporation. The acute irritation of each type of overlay worn with each fentanyl treatment was also assessed after patch removal.

Interventions

  • DRUG Mylan Fentanyl Transdermal System 25 mcg/h + Scotch Duct Tape (3M)
  • DRUG Duragesic 25 mcg/h + Scotch Duct Tape (3M)
  • DRUG Mylan Fentanyl Transdermal System 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M)
  • DRUG Duragesic 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M)
  • DRUG Mylan Fentanyl Transdermal System 25 mcg/h + Microfoam Tape (3M)

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2006-10
Est. Completion 2006-10
Phase Phase 1
Mylan Pharmaceuticals

146 total trials

What the finished NCT00650117 record still lists

NCT00650117 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 5 interventions - of which Mylan Fentanyl Transdermal System 25 mcg/h + Scotch Duct Tape (3M) is the first listed.

NCT00650117 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00650117 about?

NCT00650117 is a clinical study titled "Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System". The objective of this study was to investigate the effect of three different types of occlusive overlays on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Mylan Pharmaceuticals Inc. by Mylan Technologies Inc., and Duragesic, 25 mcg/h manufactured for Janssen Pharmaceuti...

What is the current status of trial NCT00650117?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2006-10. Estimated completion is 2006-10.

What interventions are being tested in trial NCT00650117?

The interventions under investigation include: Mylan Fentanyl Transdermal System 25 mcg/h + Scotch Duct Tape (3M) (DRUG), Duragesic 25 mcg/h + Scotch Duct Tape (3M) (DRUG), Mylan Fentanyl Transdermal System 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M) (DRUG), Duragesic 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M) (DRUG), Mylan Fentanyl Transdermal System 25 mcg/h + Microfoam Tape (3M) (DRUG).

Who is sponsoring clinical trial NCT00650117?

This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00650117's enrollment target sits among peer trials

12 1852nd of 2000 higher than 90 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 NCT00650117, the US trial registry maintained by the National Library of Medicine. NCT00650117 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.