Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System

This study has been completed.
Sponsor:
Information provided by:
Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00650117
First received: March 30, 2008
Last updated: March 31, 2008
Last verified: March 2008
  Purpose

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
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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Mylan Pharmaceuticals:

Primary Outcome Measures:
  • Drug Delivery [ Time Frame: within 30 days ] [ Designated as safety issue: No ]

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
Experimental: 1
Mylan Fentanyl Transdermal System 25 mcg/h + Scotch Duct Tape (3M)
Drug: Mylan Fentanyl Transdermal System 25 mcg/h + Scotch Duct Tape (3M)
single application
Experimental: 2
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
Experimental: 3
Mylan Fentanyl Transdermal System 25 mcg/h + Microfoam Tape (3M)
Drug: Mylan Fentanyl Transdermal System 25 mcg/h + Microfoam Tape (3M)
single application
Experimental: 4
Duragesic 25 mcg/h + Scotch Duct Tape (3M)
Drug: Duragesic 25 mcg/h + Scotch Duct Tape (3M)
single application
Experimental: 5
Duragesic 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M)
Drug: Duragesic 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M)
single application
Experimental: 6
Duragesic 25 mcg/h + Microfoam Tape (3M)
Drug: Duragesic 25 mcg/h + Microfoam Tape (3M)
single application

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age: 18 years and older.
  2. Sex: Male and/or non-pregnant, non-lactating female.

    1. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy tests performed within 21 days prior to the start of the study and on the evening prior to each dose administration. If dosing is scheduled on weekends, the HCG pregnancy test should be given within 48 hours prior to dosing of each study period. An additional serum (beta-HCG) pregnancy test will be performed upon completion of the study.
    2. 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:

      1. intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
      2. barrier methods containing or used in conjunction with a spermicidal agent, or
      3. surgical sterility (tubal ligation, oophorectomy or hysterectomy) or postmenopausal accompanied with a documented postmenopausal course of at least one year.
    3. Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:

      1. postmenopausal with an absence of menses for at least one (1) year, or
      2. bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
      3. total hysterectomy
    4. During the course of the study, from study screen until study exit, all men and women of childbearing potential must use a spermicide-containing barrier method of contraception in addition to their current contraceptive device. This requirement should be documented in the informed consent form.
  3. Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women and all subjects having a Body Mass Index (BMI) less than or equal to 30 but greater than or equal to 19. (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
  4. All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, hepatitis B and hepatitis C tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, phencyclidine, and methadone) performed within 21 days of the initial dose of study medication.

Exclusion Criteria:

  1. Institutionalized subjects will not be used.
  2. Social Habits:

    1. Use of any tobacco products within one year prior to dosing.
    2. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
    3. Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
    4. Any recent, significant change in dietary or exercise habits.
    5. A positive test for any drug included in the urine drug screen.
    6. History of drug and/or alcohol abuse.
  3. Medications:

    1. Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the initial dose of study medication.
    2. Use of any hormonal contraceptives and hormone replacement therapy within 3 months prior to study medication dosing.
    3. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
  4. Diseases:

    1. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic disease.
    2. Acute illness at the time of either the pre-study medical evaluation or dosing.
    3. A positive HIV, hepatitis B, or hepatitis C test.
  5. Abnormal and clinically significant laboratory test results:

    1. Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
    2. Abnormal and clinically relevant ECG tracing.
  6. Damaged skin in or around test sites that include sunburn, uneven skin tones, tattoos, scars or other disfigurations of the test site.
  7. Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.
  8. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication and/or participated in any transdermal system or patch study for irritation or sensitization within the last 4 weeks.
  9. Allergy or hypersensitivity to tapes or adhesives (e.g., Band-aids®, medical tape), fentanyl or naltrexone.
  10. Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650117

Locations
United States, West Virginia
Kendle International Inc.
Morgantown, West Virginia, United States, 26505
Sponsors and Collaborators
Mylan Pharmaceuticals
Investigators
Principal Investigator: Dorian Williams, M.D. Kendle International Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Will Sullivan, Global Head of Product Risk and Safety Management, Mylan Inc.
ClinicalTrials.gov Identifier: NCT00650117     History of Changes
Other Study ID Numbers: FENT-06102
Study First Received: March 30, 2008
Last Updated: March 31, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 01, 2014