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A Study to Assess the Relative Bioavailability of 4 Formulations of Fentanyl Transdermal System Compared Against DUROGESIC Fentanyl Transdermal Patch After Single Application in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01717157
First received: October 26, 2012
Last updated: March 1, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of 4 new formulations of fentanyl transdermal patch in healthy participants after a single application for 72 hours.


Condition Intervention Phase
Healthy
 Drug: Treatment A: DUROGESIC (8.4 mg fentanyl)
Drug: Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl)
Drug: Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl)
Drug: Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl)
Drug: Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, 4-Way Crossover Study to Assess the Relative Bioavailability of 4 New Formulations of Fentanyl Transdermal System Compared Against DUROGESIC Fentanyl Transdermal Patch After Single Application in Healthy Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Fentanyl serum concentrations [ Time Frame: Up to 120 hours after applying the transdermal patch ] [ Designated as safety issue: No ]
  • Determination of residual fentanyl content in the worn patchs [ Time Frame: At the end of 72 hours after applying the transdermal patch ] [ Designated as safety issue: No ]
    The fentanyl content in the patchs following their removal at the end of 72 hours

  • The skin adherence score of the patches [ Time Frame: Up to 72 hours after applying the transdermal patch ] [ Designated as safety issue: No ]
    The patch adherence will be scored from 0 to 4, where 0: >= 90% of the area adhered and no edges unattached; 1: >= 75% to < 90% adhered; 2: >= 50% and < 75% adhered; 3: > 0% and < 50% adhered, but not detached; 4: 0% adhered - patch detached.


Secondary Outcome Measures:
  • The incidence of adverse events [ Time Frame: Approximately 82 days ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: August 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment sequence 1 (AEBD) Drug: Treatment A: DUROGESIC (8.4 mg fentanyl)
One DUROGESIC transdermal patch containing 8.4 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl)
One transdermal system-concept 1 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl)
One transdermal system-concept 3 patch containing approximately 7.1 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
One transdermal system-concept 4 patch containing approximately 11.0 mg of fentanyl applied on the skin for 72 hours.
Experimental: Treatment sequence 2 (BACE) Drug: Treatment A: DUROGESIC (8.4 mg fentanyl)
One DUROGESIC transdermal patch containing 8.4 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl)
One transdermal system-concept 1 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl)
One transdermal system-concept 2 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
One transdermal system-concept 4 patch containing approximately 11.0 mg of fentanyl applied on the skin for 72 hours.
Experimental: Treatment sequence 3 (CBDA) Drug: Treatment A: DUROGESIC (8.4 mg fentanyl)
One DUROGESIC transdermal patch containing 8.4 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl)
One transdermal system-concept 1 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl)
One transdermal system-concept 2 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl)
One transdermal system-concept 3 patch containing approximately 7.1 mg of fentanyl applied on the skin for 72 hours.
Experimental: Treatment sequence 4 (EDAC) Drug: Treatment A: DUROGESIC (8.4 mg fentanyl)
One DUROGESIC transdermal patch containing 8.4 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl)
One transdermal system-concept 2 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl)
One transdermal system-concept 3 patch containing approximately 7.1 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
One transdermal system-concept 4 patch containing approximately 11.0 mg of fentanyl applied on the skin for 72 hours.
Experimental: Treatment sequence 5 (DECA) Drug: Treatment A: DUROGESIC (8.4 mg fentanyl)
One DUROGESIC transdermal patch containing 8.4 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl)
One transdermal system-concept 2 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl)
One transdermal system-concept 3 patch containing approximately 7.1 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
One transdermal system-concept 4 patch containing approximately 11.0 mg of fentanyl applied on the skin for 72 hours.
Experimental: Treatment sequence 6 (EADB) Drug: Treatment A: DUROGESIC (8.4 mg fentanyl)
One DUROGESIC transdermal patch containing 8.4 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl)
One transdermal system-concept 1 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl)
One transdermal system-concept 3 patch containing approximately 7.1 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
One transdermal system-concept 4 patch containing approximately 11.0 mg of fentanyl applied on the skin for 72 hours.
Experimental: Treatment sequence 7 (ABEC) Drug: Treatment A: DUROGESIC (8.4 mg fentanyl)
One DUROGESIC transdermal patch containing 8.4 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl)
One transdermal system-concept 1 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl)
One transdermal system-concept 2 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
One transdermal system-concept 4 patch containing approximately 11.0 mg of fentanyl applied on the skin for 72 hours.
Experimental: Treatment sequence 8 (BCAD) Drug: Treatment A: DUROGESIC (8.4 mg fentanyl)
One DUROGESIC transdermal patch containing 8.4 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl)
One transdermal system-concept 1 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl)
One transdermal system-concept 2 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
Drug: Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl)
One transdermal system-concept 3 patch containing approximately 7.1 mg of fentanyl applied on the skin for 72 hours.

Detailed Description:

This is an open-label (all people know the identity of the intervention), randomized (the study drug is assigned by chance), 4-way crossover (participants will receive different interventions sequentially during the trial) study. The study will assess the pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) and relative bioavailability (the extent to which a drug or other substance becomes available to the body) of 4 new formulations of fentanyl transdermal patch, TDS-Concept 1 50 µg/h, TDS-Concept 2 50 µg/h, TDS-Concept 3 50 µg/h and TDS-Concept 4 100 µg/h compared with DUROGESIC fentanyl 50 µg/h in healthy participants after a single application. All participants will be randomly assigned to 1 of 8 possible treatment sequences. During the 4 single-application treatment periods, each transdermal patch will be worn, on a different application site on the lateral side of the upper arm, continuously for 72 hours. The treatment periods will be separated by a washout period (period when receiving no treatment) of at least 8 and no more than 14 days. The total study length is from 64 days to a maximum of 82 days.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index (BMI; weight [kg]/height2 [m]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
  • Participants must utilize a medically acceptable method of contraception throughout the entire study period including the washout period and for 3 months (men) or 1 week (women) after the study is completed
  • Men must not donate sperm from the first drug administration until 3 months after completion of the study
  • Each participant will receive a test for opioid dependency. Only those participants that pass this challenge test will be allowed to continue in this study
  • Non-smoker

Exclusion Criteria:

  • History of or current clinically significant medical illness, disease or condition that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
  • Clinically significant abnormal laboratorial values
  • Clinically significant abnormal physical examination, vital signs or electrocardiogram (ECG)
  • Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol, oral contraceptives and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled
  • History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 5 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717157

Locations
Belgium
Antwerp, Belgium
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01717157     History of Changes
Other Study ID Numbers: CR100879, FENPAI1022, 2012-000705-71
Study First Received: October 26, 2012
Last Updated: March 1, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Janssen Research & Development, LLC:
Healthy
Fentanyl
Transdermal patch
DUROGESIC

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

ClinicalTrials.gov processed this record on May 16, 2013