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
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
3 other identifiers
interventional
32
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Aug 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 26, 2012
CompletedFirst Posted
Study publicly available on registry
October 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedMarch 6, 2014
March 1, 2014
3 months
October 26, 2012
March 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Fentanyl serum concentrations
Up to 120 hours after applying the transdermal patch
Determination of residual fentanyl content in the worn patchs
The fentanyl content in the patchs following their removal at the end of 72 hours
At the end of 72 hours after applying the transdermal patch
The skin adherence score of the patches
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.
Up to 72 hours after applying the transdermal patch
Secondary Outcomes (1)
The incidence of adverse events
Approximately 82 days
Study Arms (8)
Treatment sequence 1 (AEBD)
EXPERIMENTALTreatment sequence 2 (BACE)
EXPERIMENTALTreatment sequence 3 (CBDA)
EXPERIMENTALTreatment sequence 4 (EDAC)
EXPERIMENTALTreatment sequence 5 (DECA)
EXPERIMENTALTreatment sequence 6 (EADB)
EXPERIMENTALTreatment sequence 7 (ABEC)
EXPERIMENTALTreatment sequence 8 (BCAD)
EXPERIMENTALInterventions
One DUROGESIC transdermal patch containing 8.4 mg of fentanyl applied on the skin for 72 hours.
One transdermal system-concept 1 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
One transdermal system-concept 2 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
One transdermal system-concept 3 patch containing approximately 7.1 mg of fentanyl applied on the skin for 72 hours.
One transdermal system-concept 4 patch containing approximately 11.0 mg of fentanyl applied on the skin for 72 hours.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Antwerp, Belgium
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2012
First Posted
October 30, 2012
Study Start
August 1, 2012
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
March 6, 2014
Record last verified: 2014-03