MedTrace Logo

Study of the Effect of Clinical Procedures on Drug Delivery of Mylan Fentanyl Transdermal System 25 µg/hr and Duragesic® 25 µg/hr

NCT00648414 · Status: TERMINATED · 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 clinical procedures 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.

Conditions

  • Healthy

Interventions

DRUG

Mylan Fentanyl Transdermal System 25 mcg/h + Clinical Procedure 1

blood pressure cuff inflated directly over the transdermal system to 60-100 mmHg for 1 minute to block venous blood flow, while samples collected

DRUG

Mylan Fentanyl Transdermal System 25 mcg/h + Clinical Procedure 2

tourniquet applied just below patch application site and above blood draw site, while samples collected

DRUG

Mylan Fentanyl Transdermal System 25 mcg/h + Clinical Procedure 3

tourniquet applied just above patch application site, while samples collected

DRUG

Duragesic 25 mcg/h + Clinical Procedure 1

blood pressure cuff inflated directly over the transdermal system to 60-100 mmHg for 1 minute to block venous blood flow

DRUG

Duragesic 25 mcg/h + Clinical Procedure 2

tourniquet applied just below patch application site and above blood draw site, while samples collected

DRUG

Duragesic 25 mcg/h + Clinical Procedure 3

tourniquet applied just above patch application site, while samples collected

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
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • United States

Study Locations

More Related Trials

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 NCT00648414 on ClinicalTrials.gov