Relative Bioavailability of a Fentanyl Patch

This study has been completed.

Sponsor:

Information provided by:

Sandoz

ClinicalTrials.gov Identifier:

NCT00857753

First received: March 5, 2009

Last updated: March 6, 2009

Last verified: March 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

March 5, 2009

Last Updated Date

March 6, 2009

Start Date ^ICMJE

September 2006

Primary Completion Date

October 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Bioequivalence according to US FDA guidelines [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00857753 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Relative Bioavailability of a Fentanyl Patch

Official Title ^ICMJE

A Study to Evaluate the Relative Bioavailability of a Fentanyl PAtch Transdermal Delivery System (25 ug/hr) (Sandoz) Compared to Duragesic (Fentanyl Transdermal SYstem 25 ug/hr Patches (Alza)

Brief Summary

Tohe purpose of this study is to demonstrate the bioequivalence of a fentanyl patch transdermal delivery system.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Pain

Intervention ^ICMJE

Drug: Fentanyl patch 25 ug/nr Sandoz
Drug: Duragesic

Study Arm (s)

Experimental: 1
Fentanyl patch 25 ug/hr Sandoz

Intervention: Drug: Fentanyl patch 25 ug/nr Sandoz
Active Comparator: 2
Duragesic Patch 25 ug/hr

Intervention: Drug: Duragesic

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2006

Primary Completion Date

October 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

No clinically significant abnormal findings on physical exam, medical history or clinical laboratory tests on screening.

Exclusion Criteria:

Negative test for HIV and hepatitis B and C
No history of drug or alcohol treatment
No allergies to opiates

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00857753

Other Study ID Numbers ^ICMJE

10613401

Has Data Monitoring Committee

Not Provided

Responsible Party

Eric Mittleberg, Ph.D., VP Product Development, Sandoz, Inc.

Study Sponsor ^ICMJE

Sandoz Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Darin B. Brimhall, D.O.

Novum Pharmaceutical Research Services

Information Provided By

Sandoz

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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