Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System With Askina Derm Overlay

NCT ID: NCT00647686

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2006-07-31

Brief Summary

The objective of this study was primarily to investigate the bioequivalence and secondly to assess the wearability (adhesion) and acute irritation of Mylan fentanyl transdermal system with and without an overlay system following a single 25 µg/hr application worn for 72 hours.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

1

Fentanyl Transdermal System 25 mcg/h + Askina Derm Overlay

Group Type: EXPERIMENTAL

Fentanyl Transdermal System 25 mcg/h + Askina Derm Overlay

Intervention Type: DRUG

single application

2

Fentanyl Transdermal System 25 mcg/h

Group Type: ACTIVE_COMPARATOR

Fentanyl Transdermal System 25 mcg/h

Intervention Type: DRUG

single application

Interventions

Fentanyl Transdermal System 25 mcg/h + Askina Derm Overlay

single application

Intervention Type: DRUG

Fentanyl Transdermal System 25 mcg/h

single application

Intervention Type: DRUG

Eligibility 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. Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.

7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.

8. Allergy or hypersensitivity to tapes or adhesives (e.g., Band-aids®, medical tape), fentanyl or naltrexone.

9. Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mylan Pharmaceuticals Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Mylan Inc.

Principal Investigators

Dorian Williams, M.D.

Role: PRINCIPAL_INVESTIGATOR

Kendle International Inc.

Locations

Kendle International Inc.

Morgantown, West Virginia, United States

Countries

United States

Related Links

http://www.mpibiostudies.com

Mylan Pharmaceuticals Inc. - Clinical Trial Results

http://dailymed.nlm.nih.gov/dailymed/about.cfm

Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use

http://www.fda.gov/opacom/7alerts.html

Recalls, Market Withdrawals and Safety Alerts

Other Identifiers

FENT-0623

Identifier Type: -

Identifier Source: org_study_id