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Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System

NCT00647842 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-04-23

No results posted yet for this study

Summary

The objective of this study was primarily to investigate the bioequivalence and secondly to assess the wearability (adhesion) and acute irritation of Mylan fentanyl transdermal system with and without an overlay system following a single 25 µg/hr application worn for 72 hours.

Conditions

  • Healthy

Interventions

DRUG

Fentanyl Transdermal System 25 mcg/h + Bioclusive Overlay

single application

DRUG

Fentanyl Transdermal System 25 mcg/h

single application

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Dorian Williams, M.D. · Kendle International Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2006-02-28
Completion
2006-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00647842 on ClinicalTrials.gov