NCT02486016

Transdermal Patch CVD 2000: The Effect of Heat on Fentanyl Release From Fentanyl TDSs in Healthy Adults

Determination of Serum Fentanyl Levels After Using Reference and Generic Transdermal Fentanyl TDSs With and Without Standardized Heat Application in Healthy Human Volunteers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is an Open-label, Non-Randomized, 3-way Crossover Bioequivalence Study to compare fentanyl release after heating of a brand name (Duragesic) and generic (Apotex and Mylan) fentanyl (transdermal delivery system)TDSs in healthy adults.

Detailed description

This research study is intended to determine the effect of heat on FDA-approved fentanyl TDSs and whether the heat applied will result in more fentanyl being absorbed through the skin than without applying heat. This is important given that little is known about how the release of fentanyl is affected by heat, particularly for generic products. This study will use fentanyl TDSs (brand name and generic TDSs) that have been approved by the Food and Drug Administration (FDA) and are already prescribed to customers in the United States, and will not include any placebos.

Conditions

• Peer Review, Research

Interventions

Type	Name	Description
DRUG	Duragesic reference fentanyl TDS	25 µg/hour
DRUG	Apotex generic fentanyl TDS	25 µg/hour
DRUG	Mylan generic fentanyl TDS	25 µg/hour

Timeline

• Start date: 2015-07-09
• Primary completion: 2017-08-08
• Completion: 2017-08-09
• First posted: 2015-06-30
• Last updated: 2020-03-23
• Results posted: 2019-09-10

Locations

1 site across 1 country: United States