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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
  Purpose

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


Condition Intervention Phase
Pain
 Drug: Fentanyl patch 25 ug/nr Sandoz
Drug: Duragesic
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sandoz:

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

Enrollment: 40
Study Start Date: September 2006
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Fentanyl patch 25 ug/hr Sandoz
 Drug: Fentanyl patch 25 ug/nr Sandoz
Active Comparator: 2
Duragesic Patch 25 ug/hr
 Drug: Duragesic

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00857753

Sponsors and Collaborators
Sandoz Inc.
Investigators
Principal Investigator: Darin B. Brimhall, D.O. Novum Pharmaceutical Research Services
  More Information

No publications provided

Responsible Party: Eric Mittleberg, Ph.D., VP Product Development, Sandoz, Inc.
ClinicalTrials.gov Identifier: NCT00857753     History of Changes
Other Study ID Numbers: 10613401
Study First Received: March 5, 2009
Last Updated: March 6, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fentanyl
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 16, 2013