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

NCT00650117 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-04-23

No results posted yet for this study

Summary

The objective of this study was to investigate the effect of three different types of occlusive overlays on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Mylan Pharmaceuticals Inc. by Mylan Technologies Inc., and Duragesic, 25 mcg/h manufactured for Janssen Pharmaceutica by ALZA Corporation. The acute irritation of each type of overlay worn with each fentanyl treatment was also assessed after patch removal.

Conditions

  • Healthy

Interventions

DRUG

Mylan Fentanyl Transdermal System 25 mcg/h + Scotch Duct Tape (3M)

single application

DRUG

Duragesic 25 mcg/h + Scotch Duct Tape (3M)

single application

DRUG

Mylan Fentanyl Transdermal System 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M)

single application

DRUG

Duragesic 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M)

single application

DRUG

Mylan Fentanyl Transdermal System 25 mcg/h + Microfoam Tape (3M)

single application

DRUG

Duragesic 25 mcg/h + Microfoam Tape (3M)

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
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2006-10-31
Completion
2006-10-31

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 NCT00650117 on ClinicalTrials.gov