NCT00650117

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

Single-Dose In Vivo Bioequivalence and Wear Study of Fentanyl Transdermal System (25 µg/h; Mylan) and Fentanyl Transdermal System With Overlay (25 µg/h; Mylan) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Mylan Fentanyl Transdermal System 25 mcg/h + Scotch Duct Tape (3M)	single application
DRUG	Duragesic 25 mcg/h + Scotch Duct Tape (3M)	single application
DRUG	Mylan Fentanyl Transdermal System 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M)	single application
DRUG	Duragesic 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M)	single application
DRUG	Mylan Fentanyl Transdermal System 25 mcg/h + Microfoam Tape (3M)	single application
DRUG	Duragesic 25 mcg/h + Microfoam Tape (3M)	single application

Timeline

• Start date: 2006-10-01
• Primary completion: 2006-10-01
• Completion: 2006-10-01
• First posted: 2008-04-01
• Last updated: 2024-04-23

Locations

1 site across 1 country: United States