<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01717157</url>
  </required_header>
  <id_info>
    <org_study_id>CR100879</org_study_id>
    <secondary_id>FENPAI1022</secondary_id>
    <secondary_id>2012-000705-71</secondary_id>
    <nct_id>NCT01717157</nct_id>
  </id_info>
  <brief_title>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</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of&#xD;
      4 new formulations of fentanyl transdermal patch in healthy participants after a single&#xD;
      application for 72 hours.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label (all people know the identity of the intervention), randomized (the&#xD;
      study drug is assigned by chance), 4-way crossover (participants will receive different&#xD;
      interventions sequentially during the trial) study. The study will assess the&#xD;
      pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how&#xD;
      it is removed from the body over time) and relative bioavailability (the extent to which a&#xD;
      drug or other substance becomes available to the body) of 4 new formulations of fentanyl&#xD;
      transdermal patch, TDS-Concept 1 50 µg/h, TDS-Concept 2 50 µg/h, TDS-Concept 3 50 µg/h and&#xD;
      TDS-Concept 4 100 µg/h compared with DUROGESIC fentanyl 50 µg/h in healthy participants after&#xD;
      a single application. All participants will be randomly assigned to 1 of 8 possible treatment&#xD;
      sequences. During the 4 single-application treatment periods, each transdermal patch will be&#xD;
      worn, on a different application site on the lateral side of the upper arm, continuously for&#xD;
      72 hours. The treatment periods will be separated by a washout period (period when receiving&#xD;
      no treatment) of at least 8 and no more than 14 days. The total study length is from 64 days&#xD;
      to a maximum of 82 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fentanyl serum concentrations</measure>
    <time_frame>Up to 120 hours after applying the transdermal patch</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Determination of residual fentanyl content in the worn patchs</measure>
    <time_frame>At the end of 72 hours after applying the transdermal patch</time_frame>
    <description>The fentanyl content in the patchs following their removal at the end of 72 hours</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The skin adherence score of the patches</measure>
    <time_frame>Up to 72 hours after applying the transdermal patch</time_frame>
    <description>The patch adherence will be scored from 0 to 4, where 0: &gt;= 90% of the area adhered and no edges unattached; 1: &gt;= 75% to &lt; 90% adhered; 2: &gt;= 50% and &lt; 75% adhered; 3: &gt; 0% and &lt; 50% adhered, but not detached; 4: 0% adhered - patch detached.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidence of adverse events</measure>
    <time_frame>Approximately 82 days</time_frame>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Treatment sequence 1 (AEBD)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment sequence 2 (BACE)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment sequence 3 (CBDA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment sequence 4 (EDAC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment sequence 5 (DECA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment sequence 6 (EADB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment sequence 7 (ABEC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment sequence 8 (BCAD)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Treatment A: DUROGESIC (8.4 mg fentanyl)</intervention_name>
    <description>One DUROGESIC transdermal patch containing 8.4 mg of fentanyl applied on the skin for 72 hours.</description>
    <arm_group_label>Treatment sequence 1 (AEBD)</arm_group_label>
    <arm_group_label>Treatment sequence 2 (BACE)</arm_group_label>
    <arm_group_label>Treatment sequence 3 (CBDA)</arm_group_label>
    <arm_group_label>Treatment sequence 4 (EDAC)</arm_group_label>
    <arm_group_label>Treatment sequence 5 (DECA)</arm_group_label>
    <arm_group_label>Treatment sequence 6 (EADB)</arm_group_label>
    <arm_group_label>Treatment sequence 7 (ABEC)</arm_group_label>
    <arm_group_label>Treatment sequence 8 (BCAD)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl)</intervention_name>
    <description>One transdermal system-concept 1 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.</description>
    <arm_group_label>Treatment sequence 1 (AEBD)</arm_group_label>
    <arm_group_label>Treatment sequence 2 (BACE)</arm_group_label>
    <arm_group_label>Treatment sequence 3 (CBDA)</arm_group_label>
    <arm_group_label>Treatment sequence 6 (EADB)</arm_group_label>
    <arm_group_label>Treatment sequence 7 (ABEC)</arm_group_label>
    <arm_group_label>Treatment sequence 8 (BCAD)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl)</intervention_name>
    <description>One transdermal system-concept 2 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.</description>
    <arm_group_label>Treatment sequence 2 (BACE)</arm_group_label>
    <arm_group_label>Treatment sequence 3 (CBDA)</arm_group_label>
    <arm_group_label>Treatment sequence 4 (EDAC)</arm_group_label>
    <arm_group_label>Treatment sequence 5 (DECA)</arm_group_label>
    <arm_group_label>Treatment sequence 7 (ABEC)</arm_group_label>
    <arm_group_label>Treatment sequence 8 (BCAD)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl)</intervention_name>
    <description>One transdermal system-concept 3 patch containing approximately 7.1 mg of fentanyl applied on the skin for 72 hours.</description>
    <arm_group_label>Treatment sequence 1 (AEBD)</arm_group_label>
    <arm_group_label>Treatment sequence 3 (CBDA)</arm_group_label>
    <arm_group_label>Treatment sequence 4 (EDAC)</arm_group_label>
    <arm_group_label>Treatment sequence 5 (DECA)</arm_group_label>
    <arm_group_label>Treatment sequence 6 (EADB)</arm_group_label>
    <arm_group_label>Treatment sequence 8 (BCAD)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)</intervention_name>
    <description>One transdermal system-concept 4 patch containing approximately 11.0 mg of fentanyl applied on the skin for 72 hours.</description>
    <arm_group_label>Treatment sequence 1 (AEBD)</arm_group_label>
    <arm_group_label>Treatment sequence 2 (BACE)</arm_group_label>
    <arm_group_label>Treatment sequence 4 (EDAC)</arm_group_label>
    <arm_group_label>Treatment sequence 5 (DECA)</arm_group_label>
    <arm_group_label>Treatment sequence 6 (EADB)</arm_group_label>
    <arm_group_label>Treatment sequence 7 (ABEC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI; weight [kg]/height2 [m]2) between 18 and 30 kg/m2 (inclusive),&#xD;
             and body weight not less than 50 kg&#xD;
&#xD;
          -  Participants must utilize a medically acceptable method of contraception throughout&#xD;
             the entire study period including the washout period and for 3 months (men) or 1 week&#xD;
             (women) after the study is completed&#xD;
&#xD;
          -  Men must not donate sperm from the first drug administration until 3 months after&#xD;
             completion of the study&#xD;
&#xD;
          -  Each participant will receive a test for opioid dependency. Only those participants&#xD;
             that pass this challenge test will be allowed to continue in this study&#xD;
&#xD;
          -  Non-smoker&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of or current clinically significant medical illness, disease or condition&#xD;
             that the investigator considers should exclude the subject or that could interfere&#xD;
             with the interpretation of the study results&#xD;
&#xD;
          -  Clinically significant abnormal laboratorial values&#xD;
&#xD;
          -  Clinically significant abnormal physical examination, vital signs or electrocardiogram&#xD;
             (ECG)&#xD;
&#xD;
          -  Use of any prescription or nonprescription medication (including vitamins and herbal&#xD;
             supplements), except for paracetamol, oral contraceptives and hormonal replacement&#xD;
             therapy within 14 days before the first dose of the study drug is scheduled&#xD;
&#xD;
          -  History of, or a reason to believe a participant has a history of drug or alcohol&#xD;
             abuse within the past 5 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Antwerp</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>March 5, 2014</last_update_submitted>
  <last_update_submitted_qc>March 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy</keyword>
  <keyword>Fentanyl</keyword>
  <keyword>Transdermal patch</keyword>
  <keyword>DUROGESIC</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01717157
org study id: CR100879
secondary id: FENPAI1022
secondary id: 2012-000705-71
nct id: NCT01717157
lead sponsor: 
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Fentanyl serum concentrations
time frame: Up to 120 hours after applying the transdermal patch
measure: Determination of residual fentanyl content in the worn patchs
time frame: At the end of 72 hours after applying the transdermal patch
description: The fentanyl content in the patchs following their removal at the end of 72 hours
measure: The skin adherence score of the patches
time frame: Up to 72 hours after applying the transdermal patch
description: 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.
measure: The incidence of adverse events
time frame: Approximately 82 days
arm group label: Treatment sequence 1 (AEBD)
arm group type: Experimental
arm group label: Treatment sequence 2 (BACE)
arm group type: Experimental
arm group label: Treatment sequence 3 (CBDA)
arm group type: Experimental
arm group label: Treatment sequence 4 (EDAC)
arm group type: Experimental
arm group label: Treatment sequence 5 (DECA)
arm group type: Experimental
arm group label: Treatment sequence 6 (EADB)
arm group type: Experimental
arm group label: Treatment sequence 7 (ABEC)
arm group type: Experimental
arm group label: Treatment sequence 8 (BCAD)
arm group type: Experimental
intervention type: Drug
intervention name: Treatment A: DUROGESIC (8.4 mg fentanyl)
description: One DUROGESIC transdermal patch containing 8.4 mg of fentanyl applied on the skin for 72 hours.
arm group label: Treatment sequence 1 (AEBD)
arm group label: Treatment sequence 2 (BACE)
arm group label: Treatment sequence 3 (CBDA)
arm group label: Treatment sequence 4 (EDAC)
arm group label: Treatment sequence 5 (DECA)
arm group label: Treatment sequence 6 (EADB)
arm group label: Treatment sequence 7 (ABEC)
arm group label: Treatment sequence 8 (BCAD)
intervention type: Drug
intervention name: Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl)
description: One transdermal system-concept 1 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
arm group label: Treatment sequence 1 (AEBD)
arm group label: Treatment sequence 2 (BACE)
arm group label: Treatment sequence 3 (CBDA)
arm group label: Treatment sequence 6 (EADB)
arm group label: Treatment sequence 7 (ABEC)
arm group label: Treatment sequence 8 (BCAD)
intervention type: Drug
intervention name: Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl)
description: One transdermal system-concept 2 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
arm group label: Treatment sequence 2 (BACE)
arm group label: Treatment sequence 3 (CBDA)
arm group label: Treatment sequence 4 (EDAC)
arm group label: Treatment sequence 5 (DECA)
arm group label: Treatment sequence 7 (ABEC)
arm group label: Treatment sequence 8 (BCAD)
intervention type: Drug
intervention name: Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl)
description: One transdermal system-concept 3 patch containing approximately 7.1 mg of fentanyl applied on the skin for 72 hours.
arm group label: Treatment sequence 1 (AEBD)
arm group label: Treatment sequence 3 (CBDA)
arm group label: Treatment sequence 4 (EDAC)
arm group label: Treatment sequence 5 (DECA)
arm group label: Treatment sequence 6 (EADB)
arm group label: Treatment sequence 8 (BCAD)
intervention type: Drug
intervention name: Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
description: One transdermal system-concept 4 patch containing approximately 11.0 mg of fentanyl applied on the skin for 72 hours.
arm group label: Treatment sequence 1 (AEBD)
arm group label: Treatment sequence 2 (BACE)
arm group label: Treatment sequence 4 (EDAC)
arm group label: Treatment sequence 5 (DECA)
arm group label: Treatment sequence 6 (EADB)
arm group label: Treatment sequence 7 (ABEC)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Fentanyl