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Sponsored by: |
Mylan Pharmaceuticals |
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Information provided by: | Mylan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00650117 |
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.
Condition | Intervention | Phase |
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Healthy |
Drug: Mylan Fentanyl Transdermal System 25 mcg/h + Scotch Duct Tape (3M) Drug: Duragesic 25 mcg/h + Scotch Duct Tape (3M) Drug: Mylan Fentanyl Transdermal System 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M) Drug: Duragesic 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M) Drug: Mylan Fentanyl Transdermal System 25 mcg/h + Microfoam Tape (3M) Drug: Duragesic 25 mcg/h + Microfoam Tape (3M) |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study |
Official Title: | Single-Dose In Vivo Bioequivalence and Wear Study of Fentanyl Transdermal System (25 µg/h; Mylan) and Fentanyl Transdermal System With Overlay (25 µg/h; Mylan) in Healthy Volunteers |
Enrollment: | 12 |
Study Start Date: | October 2006 |
Study Completion Date: | October 2006 |
Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Mylan Fentanyl Transdermal System 25 mcg/h + Scotch Duct Tape (3M)
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Drug: Mylan Fentanyl Transdermal System 25 mcg/h + Scotch Duct Tape (3M)
single application
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2: Experimental
Mylan Fentanyl Transdermal System 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M)
|
Drug: Mylan Fentanyl Transdermal System 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M)
single application
|
3: Experimental
Mylan Fentanyl Transdermal System 25 mcg/h + Microfoam Tape (3M)
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Drug: Mylan Fentanyl Transdermal System 25 mcg/h + Microfoam Tape (3M)
single application
|
4: Experimental
Duragesic 25 mcg/h + Scotch Duct Tape (3M)
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Drug: Duragesic 25 mcg/h + Scotch Duct Tape (3M)
single application
|
5: Experimental
Duragesic 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M)
|
Drug: Duragesic 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M)
single application
|
6: Experimental
Duragesic 25 mcg/h + Microfoam Tape (3M)
|
Drug: Duragesic 25 mcg/h + Microfoam Tape (3M)
single application
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sex: Male and/or non-pregnant, non-lactating female.
Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormone replacement therapy are permitted in this study. Acceptable forms of contraception include the following:
Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
Exclusion Criteria:
Social Habits:
Medications:
Diseases:
Abnormal and clinically significant laboratory test results:
United States, West Virginia | |
Kendle International Inc. | |
Morgantown, West Virginia, United States, 26505 |
Principal Investigator: | Dorian Williams, M.D. | Kendle International Inc. |
Responsible Party: | Mylan Inc. ( Will Sullivan, Global Head of Product Risk and Safety Management ) |
Study ID Numbers: | FENT-06102 |
Study First Received: | March 30, 2008 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00650117 |
Health Authority: | United States: Institutional Review Board |
Fentanyl Healthy |
Anesthetics, Intravenous Physiological Effects of Drugs Central Nervous System Depressants Anesthetics Narcotics Pharmacologic Actions Adjuvants, Anesthesia |
Sensory System Agents Anesthetics, General Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |