Ignite Creation Date:
2024-05-06 @ 7:27 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02531971
Status:
COMPLETED
Last Update Posted:
2020-03-26
First Post:
2015-08-19
Brief Title:
Fentanyl Patch Pharmacokinetics in Healthy Adults
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Absolute Bioavailability Pharmacokinetic and Residual Drug Analysis of Duragesic Transdermal System and Generic Fentanyl Transdermal System in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None