NCT02531971

Fentanyl Patch Pharmacokinetics in Healthy Adults

Absolute Bioavailability/ Pharmacokinetic and Residual Drug Analysis of Duragesic ® Transdermal System and Generic Fentanyl Transdermal System in Healthy Adults

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study to be performed will utilize already FDA-approved marketed products in healthy adults for the purpose to generate data for establishing rate of drug delivery comparisons between RLD (reference listed drug) Duragesic ® TDDS (transdermal drug delivery system) and Generic Fentanyl TDDS in healthy adults and to ensure safety of individuals utilizing these types of products.

Detailed description

Transdermal drug delivery systems (TDDS) available in the form of patches are convenient, attractive, and easy to use systems. Fentanyl patches are very popular TDDS available on the United States market today. Accurate determination of the rate and extent of drug release and absorption is crucial to ensure the safety of individuals using these and other types of patches. Delivery rate can be determined early in the development process by using in vitro skin flux permeation studies, and later in humans by accurately quantifying residual drug from patches post-wear and in pharmacokinetic studies. In this proposal, we will employ two types of evaluation to determine the rate and extent of drug release and absorption from RLD (reference listed drug) Duragesic ® TDDS (transdermal drug delivery system) and Generic Fentanyl TDDS, namely residual drug analysis post-wear and pharmacokinetic analysis in healthy adult volunteers. In addition, we will compare the plasma drug concentrations following patch and intravenous administration of Fentanyl, in order to determine the absolute bioavailability of these patches. We will conduct residual drug analysis of TDDS following in vivo wear using highly sensitive validated quantification methods. Positive outcome of this project will identify appropriate methods to determine the rate and extent of drug release and absorption from TDDS, and will help regulatory agencies in the development of Guidances for Industry regarding the characterization of drug release and absorption kinetics to ensure the safety of individuals utilizing these types of products

Conditions

• Peer Review, Research

Interventions

Type	Name	Description
DRUG	Intravenous fentanyl citrate	100 micrograms (2 millilitres) via intravenous injection
DRUG	Duragesic®	TDDS dosage is 25 micrograms/hour (worn for 72 h)
DRUG	Mylan generic fentanyl	TDDS dosage is 25 micrograms/hour (worn for 72 h)

Timeline

• Start date: 2016-01-14
• Primary completion: 2018-10-16
• Completion: 2018-10-16
• First posted: 2015-08-25
• Last updated: 2020-03-26
• Results posted: 2020-03-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study