Relative Bioavailability of a Fentanyl Patch

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00857753
Recruitment Status : Completed
First Posted : March 9, 2009
Last Update Posted : March 29, 2017
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Brief Summary:
Tohe purpose of this study is to demonstrate the bioequivalence of a fentanyl patch transdermal delivery system.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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)
Study Start Date : September 2006
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Bioequivalence according to US FDA guidelines [ Time Frame: 3 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00857753

Sponsors and Collaborators
Principal Investigator: Darin B. Brimhall, D.O. Novum Pharmaceutical Research Services

Responsible Party: Eric Mittleberg, Ph.D., VP Product Development, Sandoz, Inc. Identifier: NCT00857753     History of Changes
Other Study ID Numbers: 10613401
First Posted: March 9, 2009    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2009

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