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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Mylan Fentanyl Transdermal System 25 mcg/h + Scotch Duct Tape (3M); Drug: Mylan Fentanyl Transdermal System 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 + Scotch Duct Tape (3M); Drug: Duragesic 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M); Drug: Duragesic 25 mcg/h + Microfoam Tape (3M)

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Kendle International Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Drug Delivery	within 30 days

Collaborators and Investigators

• Sponsor: Mylan Pharmaceuticals Inc
• Investigators: Principal Investigator: Dorian Williams, M.D., Kendle International Inc.

Publications and helpful links

Helpful Links

• Mylan Pharmaceuticals Inc. - Clinical Trial Results
• Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use
• Recalls, Market Withdrawals and Safety Alerts

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: March 30, 2008
• First Submitted That Met QC Criteria: March 31, 2008
• First Posted (Estimated): April 1, 2008

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: FENT-06102