CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 24 enrolled
Drug / intervention
Intravenous fentanyl citrate +2 moredrug
Likely dose
Intravenous fentanyl citrate 100 microgramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02531971
NCT02531971Phase 4Completed
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Absolute Bioavailability/ Pharmacokinetic and Residual Drug Analysis of Duragesic ® Transdermal System and Generic Fentanyl Transdermal System in Healthy Adults

University of Maryland, Baltimore·interventional·Posted Aug 25, 2015·Updated Mar 26, 2020

In Brief

A Phase 4 clinical trial evaluating Intravenous fentanyl citrate, Duragesic®, and 1 other intervention for Peer Review, Research. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeer Review, Research
CountriesUnited States
CollaboratorsFood and Drug Administration (FDA)

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 25, 2015
Enrollment StartJan 14, 2016
Primary CompletionOct 16, 2018
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.9 years ago

Interventions

Intravenous fentanyl citratedrug

100 micrograms (2 millilitres) via intravenous injection

Duragesic®drug

TDDS dosage is 25 micrograms/hour (worn for 72 h)

Mylan generic fentanyldrug

TDDS dosage is 25 micrograms/hour (worn for 72 h)