NCT00864565

A Relative Bioavailability Study of Fentanyl 25 μg/h Transdermal System

Randomized, 2-way Crossover, Bioequivalence Study of Fentanyl 25 μg/h Transdermal System and Duragesic 25 μg/h Transdermal System Administrated as 1 x 25 μg/h Single Application in the Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To compare the rate and extent of absorption of fentanyl 25 μg/h transdermal system (test) and Duragesic (reference) administrated as 1 x 25 μg/h single transdermal system application.

Detailed description

Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design. Official Title: Randomized, 2-way crossover, bioequivalence study of Fentanyl 25 μg/h transdermal system and Duragesic 25 μg/h transdermal system administrated as 1 x 25 μg/h single application in the healthy subjects Further study details as provided by Actavis Elizabeth LLC: Primary Outcome Measures: Rate and Extend of Absorption

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Fentanyl 25 μg/h transdermal system, single application	A: Experimental Subjects received Corium International, Inc formulated products
DRUG	Duragesic 25 μg/h transdermal system single application	B: Active comparator Subjects received Jassen Pharmaceutica Products, L.P. formulated products

Timeline

• Start date: 2003-06-01
• Primary completion: 2003-06-01
• Completion: 2003-06-01
• First posted: 2009-03-18
• Last updated: 2010-08-16

Locations

1 site across 1 country: Canada