NCT00647842

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: 120 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Fentanyl Transdermal System 25 mcg/h + Bioclusive Overlay	single application
DRUG	Fentanyl Transdermal System 25 mcg/h	single application

Timeline

• Start date: 2005-11-01
• Primary completion: 2006-02-01
• Completion: 2006-02-01
• First posted: 2008-04-01
• Last updated: 2024-04-23

Locations

1 site across 1 country: United States