CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 10 enrolled
Drug / intervention
Duragesic reference fentanyl TDS +2 moredrug
Likely dose
Duragesic reference fentanyl TDS 25 µgfrom 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/NCT02486016
NCT02486016Phase 4Completed
CompareCT.gov

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

University of Maryland, Baltimore·interventional·Posted Jun 30, 2015·Updated Mar 23, 2020

In Brief

A Phase 4 clinical trial evaluating Duragesic reference fentanyl TDS, Apotex generic fentanyl TDS, and 1 other intervention for Peer Review, Research. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

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

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 30, 2015
Enrollment StartJul 9, 2015
Primary CompletionAug 8, 2017
Study CompletionAug 9, 2017
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 11.0 years ago

Interventions

Duragesic reference fentanyl TDSdrug

25 µg/hour

Apotex generic fentanyl TDSdrug

25 µg/hour

Mylan generic fentanyl TDSdrug

25 µg/hour