<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/NCT02201238</url>
  </required_header>
  <id_info>
    <org_study_id>202188</org_study_id>
    <secondary_id>RH02175</secondary_id>
    <nct_id>NCT02201238</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics Study Comparing Topical Diclofenac/Menthol Gels With Voltaren Gel and Oral Diclofenac Sodium</brief_title>
  <official_title>A Pharmacokinetics Study Comparing Systemic Exposure of Topical Diclofenac/Menthol Gels Versus Voltaren Gel and Oral Diclofenac Sodium in Healthy Volunteers at Steady State</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study is being conducted to characterize the pharmacokinetic properties of a&#xD;
      new topical medication (MFC51123) that contains two active ingredients (diclofenac and&#xD;
      menthol) in two formulation packages. One formulation package is in the form of a gel in&#xD;
      aluminum tube and the other one in the form of a gel in roll-on applicator bottle.&#xD;
      Additionally, as a comparison, the pharmacokinetic properties of a marketed diclofenac gel&#xD;
      and an oral diclofenac treatment will also be characterized. This topical diclofenac/menthol&#xD;
      gel has being developed to treat mild to moderate pain and inflammation, such as acute sport&#xD;
      injuries, sprains and strains. The rationale for conducting the study is to prove that&#xD;
      repeated topical treatment of the new diclofenac + menthol formulation in either of the two&#xD;
      packages does not result in unsafe systemic exposure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2014</start_date>
  <completion_date type="Actual">November 21, 2014</completion_date>
  <primary_completion_date type="Actual">November 21, 2014</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC48-72 hrs of Diclofenac gel in tube/AUC48-72 hrs of oral Diclofenac</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of area under the plasma concentration time curve from 48-72 hrs (AUC48-72 hrs) of Diclofenac gel in tube and AUC48-72 hrs of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from oral Diclofenac</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Diclofenac gel in tube/Cmax of oral Diclofenac</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of maximum plasma concentration (Cmax) of Diclofenac gel in tube and Cmax of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from oral Diclofenac</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC48-72 hrs of Diclofenac gel in roll-on device/AUC48-72 hrs of oral Diclofenac</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of AUC48-72 hrs of Diclofenac gel in roll-on device and AUC48-72 hrs of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from roll-on device as compared to that from oral Diclofenac</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Diclofenac gel in roll-on device/Cmax of oral Diclofenac</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of Cmax of Diclofenac gel in roll-on device and Cmax of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from roll-on device as compared to that from oral Diclofenac</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmin of Diclofenac gel in tube/Cmin of oral Diclofenac</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of minimum plasma concentration (Cmin) of Diclofenac gel in tube and Cmin of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from oral Diclofenac</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax of Diclofenac gel in tube/Tmax of oral Diclofenac</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of time to maximum plasma concentration (Tmax) of Diclofenac gel in tube and Tmax of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from oral Diclofenac</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmin of Diclofenac gel in roll-on device/Cmin of oral Diclofenac</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of Cmin of Diclofenac gel in roll-on device and Cmin of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from roll-on device as compared to that from oral Diclofenac</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax of Diclofenac gel in roll-on device/Tmax of oral Diclofenac</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of Tmax of Diclofenac gel in roll-on device and Tmax of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from roll-on device as compared to that from oral Diclofenac</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax of Diclofenac gel in tube/Cmax of Diclofenac in Voltaren gel</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of Cmax of Diclofenac gel in tube and Cmax of Voltaren gel during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from Voltaren gel</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax of Diclofenac gel in roll-on device/Cmax of Diclofenac in Voltaren gel</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of Cmax of Diclofenac gel in roll-on device and Cmax of Voltaren gel during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from roll-on device as compared to that from Voltaren gel</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmin of Diclofenac gel in tube/Cmin of Diclofenac in Voltaren gel</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of Cmin of Diclofenac gel in tube and Cmin of Voltaren gel during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from Voltaren gel</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmin of Diclofenac gel in roll-on device/Cmin of Diclofenac in Voltaren gel</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of Cmin of Diclofenac gel in roll-on device and Cmin of Voltaren gel during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from roll-on device as compared to that from Voltaren gel</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC48-72 hrs of Diclofenac gel in tube/AUC48-72 hrs of Diclofenac in Voltaren gel</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of AUC48-72 hrs of Diclofenac gel in tube and AUC48-72 hrs of Voltaren gel during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from Voltaren gel</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC48-72 hrs of Diclofenac gel in roll-on device/AUC48-72 hrs of Diclofenac in Voltaren gel</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of AUC48-72 hrs of Diclofenac gel in roll-on device and AUC48-72 hrs of Voltaren gel during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from roll-on device as compared to that from Voltaren gel</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax of Diclofenac gel in tube/Tmax of Diclofenac in Voltaren gel</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of Tmax of Diclofenac gel in tube and Tmax of Voltaren during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from Voltaren gel</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax of Diclofenac gel in roll-on device/Tmax of Diclofenac in Voltaren gel</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of Tmax of Diclofenac gel in roll-on device and Tmax of Voltaren during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from roll-on device as compared to that from Voltaren gel</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax of Menthol in gel/Cmax of Menthol reported in literature</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of Cmax of Menthol in tube and Cmax of Menthol reported in literature will assess systemic exposure to menthol from gel tube as compared to that reported in literature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax of Menthol in roll-on device/Cmax of Menthol reported in literature</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of Cmax of Menthol in roll-on device and Cmax of Menthol reported in literature will assess systemic exposure of menthol from roll-on device as compared to that reported in literature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmin of Menthol in gel/Cmin of Menthol reported in literature</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of Cmin of Menthol in tube and Cmin of Menthol reported in literature will assess systemic exposure to menthol from gel tube as compared to that reported in literature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmin of Menthol in roll-on device/Cmin of Menthol reported in literature</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of Cmin of Menthol in roll-on device and Cmin of Menthol reported in literature will assess systemic exposure of menthol from roll-on device as compared to that reported in literature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax of Menthol in gel/Tmax of Menthol reported in literature</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of Tmax of Menthol in tube and Tmax of Menthol reported in literature will assess systemic exposure to menthol from gel tube as compared to that reported in literature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax of Menthol in roll-on device/Tmax of Menthol reported in literature</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of Tmax of Menthol in roll-on device and Tmax of Menthol reported in literature will assess systemic exposure of menthol from roll-on device as compared to that reported in literature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T1/2 of Menthol in gel/T1/2 of Menthol reported in literature</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of half time elimination (T1/2) of Menthol in tube and T1/2 of Menthol reported in literature will assess systemic exposure to menthol from gel tube as compared to that reporetd in literature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T1/2 of Menthol in roll-on device/T1/2 of Menthol reported in literature</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of T1/2 of Menthol in roll-on device and T1/2 of Menthol reported in literature will assess systemic exposure of menthol from roll-on device as compared to that reported in literature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC48-72 hrs of Menthol in gel/AUC48-72 hrs of Menthol reported in literature</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of AUC48-72 hrs of Menthol in gel and AUC48-72 hrs of Menthol reported in literature will assess systemic exposure to menthol from gel tube as compared to that reported in literature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC48-72 hrs of Menthol in roll-on device/AUC48-72 hrs of Menthol reported in literature</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of AUC48-72 hrs of Menthol in roll-on device and AUC48-72 hrs of Menthol reported in literature will assess systemic exposure of menthol from roll-on device as compared to that reported in literature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC48-72 hrs of Voltaren gel/AUC48-72 hrs of oral Diclofenac</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of AUC48-72 hrs of Voltaren gel and AUC48-72 hrs of oral Diclofenac will assess systemic exposure of Voltaren gel as compared to oral Diclofenac</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax of Voltaren gel/Cmax of oral Diclofenac</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of Cmax of Voltaren gel and Cmax of oral Diclofenac will assess systemic exposure of Voltaren gel as compared to oral Diclofenac</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T1/2 of Diclofenac gel in tube/T1/2 of oral Diclofenac</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of T1/2 of Diclofenac gel in tube and T1/2 of oral Diclofenac will assess systemic exposure to Diclofenac from gel as compared to that from oral Diclofenac</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T1/2 of Diclofenac gel in roll-on device/T1/2 of oral Diclofenac</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of T1/2 of Diclofenac gel in roll-on device and T1/2 of oral Diclofenac will assess systemic exposure to Diclofenac from roll-on device as compared to that from oral Diclofenac</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T1/2 of Diclofenac gel in tube/T1/2 of Diclofenac in Voltaren gel</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of T1/2 of Diclofenac gel in tube and T1/2 of Voltaren gel will assess systemic exposure to Diclofenac from gel tube as compared to that from Voltaren gel</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T1/2 of Diclofenac gel in roll-on device/T1/2 of Diclofenac in Voltaren gel</measure>
    <time_frame>20 days</time_frame>
    <description>Ratio of T1/2 of Diclofenac gel in roll-on device and T1/2 of Voltaren gel will assess systemic exposure to Diclofenac from roll-on device as compared to that from Voltaren gel</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse event monitoring</measure>
    <time_frame>27 days</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Diclofenac sodium/menthol gel (in tube)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1% diclofenac sodium plus 3% menthol gel (in 30g aluminium tube). Dose given- 4g applied topically to a 400cm2 (20cm x 20cm) area of the skin, four times daily for three consecutive days with 5h between adjacent doses on the same day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diclofenac sodium/menthol gel (in roll-on device)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1% diclofenac sodium plus 3% menthol gel (in roll-on applicator device supplied in 30g plastic bottles). Dose given- 4g applied topically to a 400cm2 (20cm x 20cm) area of the skin, four times daily for three consecutive days with 5h between adjacent doses on the same day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diclofenac sodium tablets</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>50mg diclofenac sodium tablets administered orally, three times daily for three consecutive days with 6h between adjacent doses on the same day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Voltaren gel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Voltaren gel supplied in 100g aluminium tube. Dose given- 4g applied topically to a 400cm2 (20cm x 20cm) area of the skin, four times daily for three consecutive days with 5h between adjacent doses on the same day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diclofenac sodium</intervention_name>
    <description>Diclofenac sodium</description>
    <arm_group_label>Diclofenac sodium tablets</arm_group_label>
    <arm_group_label>Diclofenac sodium/menthol gel (in roll-on device)</arm_group_label>
    <arm_group_label>Diclofenac sodium/menthol gel (in tube)</arm_group_label>
    <arm_group_label>Voltaren gel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Menthol</intervention_name>
    <description>Menthol</description>
    <arm_group_label>Diclofenac sodium/menthol gel (in roll-on device)</arm_group_label>
    <arm_group_label>Diclofenac sodium/menthol gel (in tube)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants aged 18 to 50 years&#xD;
&#xD;
          -  Body mass index between 19-28 (kg/m2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating females&#xD;
&#xD;
          -  Participants having intolerance or hypersensitivity to study material&#xD;
&#xD;
          -  Participants having positive results for HIV, Hepatitis B or Hepatitis C&#xD;
&#xD;
          -  Participants having skin lesion at site of application&#xD;
&#xD;
          -  Participants having history of alcohol or drug abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>June 28, 2017</last_update_submitted>
  <last_update_submitted_qc>June 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diclofenac</mesh_term>
    <mesh_term>Menthol</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/NCT02201238
org study id: 202188
secondary id: RH02175
nct id: NCT02201238
lead sponsor: 
has dmc: No
This research study is being conducted to characterize the pharmacokinetic properties of a
      new topical medication (MFC51123) that contains two active ingredients (diclofenac and
      menthol) in two formulation packages. One formulation package is in the form of a gel in
      aluminum tube and the other one in the form of a gel in roll-on applicator bottle.
      Additionally, as a comparison, the pharmacokinetic properties of a marketed diclofenac gel
      and an oral diclofenac treatment will also be characterized. This topical diclofenac/menthol
      gel has being developed to treat mild to moderate pain and inflammation, such as acute sport
      injuries, sprains and strains. The rationale for conducting the study is to prove that
      repeated topical treatment of the new diclofenac + menthol formulation in either of the two
      packages does not result in unsafe systemic exposure.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: AUC48-72 hrs of Diclofenac gel in tube/AUC48-72 hrs of oral Diclofenac
time frame: 20 days
description: Ratio of area under the plasma concentration time curve from 48-72 hrs (AUC48-72 hrs) of Diclofenac gel in tube and AUC48-72 hrs of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from oral Diclofenac
measure: Cmax of Diclofenac gel in tube/Cmax of oral Diclofenac
time frame: 20 days
description: Ratio of maximum plasma concentration (Cmax) of Diclofenac gel in tube and Cmax of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from oral Diclofenac
measure: AUC48-72 hrs of Diclofenac gel in roll-on device/AUC48-72 hrs of oral Diclofenac
time frame: 20 days
description: Ratio of AUC48-72 hrs of Diclofenac gel in roll-on device and AUC48-72 hrs of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from roll-on device as compared to that from oral Diclofenac
measure: Cmax of Diclofenac gel in roll-on device/Cmax of oral Diclofenac
time frame: 20 days
description: Ratio of Cmax of Diclofenac gel in roll-on device and Cmax of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from roll-on device as compared to that from oral Diclofenac
measure: Cmin of Diclofenac gel in tube/Cmin of oral Diclofenac
time frame: 20 days
description: Ratio of minimum plasma concentration (Cmin) of Diclofenac gel in tube and Cmin of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from oral Diclofenac
measure: Tmax of Diclofenac gel in tube/Tmax of oral Diclofenac
time frame: 20 days
description: Ratio of time to maximum plasma concentration (Tmax) of Diclofenac gel in tube and Tmax of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from oral Diclofenac
measure: Cmin of Diclofenac gel in roll-on device/Cmin of oral Diclofenac
time frame: 20 days
description: Ratio of Cmin of Diclofenac gel in roll-on device and Cmin of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from roll-on device as compared to that from oral Diclofenac
measure: Tmax of Diclofenac gel in roll-on device/Tmax of oral Diclofenac
time frame: 20 days
description: Ratio of Tmax of Diclofenac gel in roll-on device and Tmax of oral Diclofenac during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from roll-on device as compared to that from oral Diclofenac
measure: Cmax of Diclofenac gel in tube/Cmax of Diclofenac in Voltaren gel
time frame: 20 days
description: Ratio of Cmax of Diclofenac gel in tube and Cmax of Voltaren gel during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from Voltaren gel
measure: Cmax of Diclofenac gel in roll-on device/Cmax of Diclofenac in Voltaren gel
time frame: 20 days
description: Ratio of Cmax of Diclofenac gel in roll-on device and Cmax of Voltaren gel during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from roll-on device as compared to that from Voltaren gel
measure: Cmin of Diclofenac gel in tube/Cmin of Diclofenac in Voltaren gel
time frame: 20 days
description: Ratio of Cmin of Diclofenac gel in tube and Cmin of Voltaren gel during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from Voltaren gel
measure: Cmin of Diclofenac gel in roll-on device/Cmin of Diclofenac in Voltaren gel
time frame: 20 days
description: Ratio of Cmin of Diclofenac gel in roll-on device and Cmin of Voltaren gel during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from roll-on device as compared to that from Voltaren gel
measure: AUC48-72 hrs of Diclofenac gel in tube/AUC48-72 hrs of Diclofenac in Voltaren gel
time frame: 20 days
description: Ratio of AUC48-72 hrs of Diclofenac gel in tube and AUC48-72 hrs of Voltaren gel during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from Voltaren gel
measure: AUC48-72 hrs of Diclofenac gel in roll-on device/AUC48-72 hrs of Diclofenac in Voltaren gel
time frame: 20 days
description: Ratio of AUC48-72 hrs of Diclofenac gel in roll-on device and AUC48-72 hrs of Voltaren gel during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from roll-on device as compared to that from Voltaren gel
measure: Tmax of Diclofenac gel in tube/Tmax of Diclofenac in Voltaren gel
time frame: 20 days
description: Ratio of Tmax of Diclofenac gel in tube and Tmax of Voltaren during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from gel as compared to that from Voltaren gel
measure: Tmax of Diclofenac gel in roll-on device/Tmax of Diclofenac in Voltaren gel
time frame: 20 days
description: Ratio of Tmax of Diclofenac gel in roll-on device and Tmax of Voltaren during the final 24 hours of dosing at steady state will assess systemic exposure to Diclofenac from roll-on device as compared to that from Voltaren gel
measure: Cmax of Menthol in gel/Cmax of Menthol reported in literature
time frame: 20 days
description: Ratio of Cmax of Menthol in tube and Cmax of Menthol reported in literature will assess systemic exposure to menthol from gel tube as compared to that reported in literature
measure: Cmax of Menthol in roll-on device/Cmax of Menthol reported in literature
time frame: 20 days
description: Ratio of Cmax of Menthol in roll-on device and Cmax of Menthol reported in literature will assess systemic exposure of menthol from roll-on device as compared to that reported in literature
measure: Cmin of Menthol in gel/Cmin of Menthol reported in literature
time frame: 20 days
description: Ratio of Cmin of Menthol in tube and Cmin of Menthol reported in literature will assess systemic exposure to menthol from gel tube as compared to that reported in literature
measure: Cmin of Menthol in roll-on device/Cmin of Menthol reported in literature
time frame: 20 days
description: Ratio of Cmin of Menthol in roll-on device and Cmin of Menthol reported in literature will assess systemic exposure of menthol from roll-on device as compared to that reported in literature
measure: Tmax of Menthol in gel/Tmax of Menthol reported in literature
time frame: 20 days
description: Ratio of Tmax of Menthol in tube and Tmax of Menthol reported in literature will assess systemic exposure to menthol from gel tube as compared to that reported in literature
measure: Tmax of Menthol in roll-on device/Tmax of Menthol reported in literature
time frame: 20 days
description: Ratio of Tmax of Menthol in roll-on device and Tmax of Menthol reported in literature will assess systemic exposure of menthol from roll-on device as compared to that reported in literature
measure: T1/2 of Menthol in gel/T1/2 of Menthol reported in literature
time frame: 20 days
description: Ratio of half time elimination (T1/2) of Menthol in tube and T1/2 of Menthol reported in literature will assess systemic exposure to menthol from gel tube as compared to that reporetd in literature
measure: T1/2 of Menthol in roll-on device/T1/2 of Menthol reported in literature
time frame: 20 days
description: Ratio of T1/2 of Menthol in roll-on device and T1/2 of Menthol reported in literature will assess systemic exposure of menthol from roll-on device as compared to that reported in literature
measure: AUC48-72 hrs of Menthol in gel/AUC48-72 hrs of Menthol reported in literature
time frame: 20 days
description: Ratio of AUC48-72 hrs of Menthol in gel and AUC48-72 hrs of Menthol reported in literature will assess systemic exposure to menthol from gel tube as compared to that reported in literature
measure: AUC48-72 hrs of Menthol in roll-on device/AUC48-72 hrs of Menthol reported in literature
time frame: 20 days
description: Ratio of AUC48-72 hrs of Menthol in roll-on device and AUC48-72 hrs of Menthol reported in literature will assess systemic exposure of menthol from roll-on device as compared to that reported in literature
measure: AUC48-72 hrs of Voltaren gel/AUC48-72 hrs of oral Diclofenac
time frame: 20 days
description: Ratio of AUC48-72 hrs of Voltaren gel and AUC48-72 hrs of oral Diclofenac will assess systemic exposure of Voltaren gel as compared to oral Diclofenac
measure: Cmax of Voltaren gel/Cmax of oral Diclofenac
time frame: 20 days
description: Ratio of Cmax of Voltaren gel and Cmax of oral Diclofenac will assess systemic exposure of Voltaren gel as compared to oral Diclofenac
measure: T1/2 of Diclofenac gel in tube/T1/2 of oral Diclofenac
time frame: 20 days
description: Ratio of T1/2 of Diclofenac gel in tube and T1/2 of oral Diclofenac will assess systemic exposure to Diclofenac from gel as compared to that from oral Diclofenac
measure: T1/2 of Diclofenac gel in roll-on device/T1/2 of oral Diclofenac
time frame: 20 days
description: Ratio of T1/2 of Diclofenac gel in roll-on device and T1/2 of oral Diclofenac will assess systemic exposure to Diclofenac from roll-on device as compared to that from oral Diclofenac
measure: T1/2 of Diclofenac gel in tube/T1/2 of Diclofenac in Voltaren gel
time frame: 20 days
description: Ratio of T1/2 of Diclofenac gel in tube and T1/2 of Voltaren gel will assess systemic exposure to Diclofenac from gel tube as compared to that from Voltaren gel
measure: T1/2 of Diclofenac gel in roll-on device/T1/2 of Diclofenac in Voltaren gel
time frame: 20 days
description: Ratio of T1/2 of Diclofenac gel in roll-on device and T1/2 of Voltaren gel will assess systemic exposure to Diclofenac from roll-on device as compared to that from Voltaren gel
measure: Adverse event monitoring
time frame: 27 days
arm group label: Diclofenac sodium/menthol gel (in tube)
arm group type: Experimental
description: 1% diclofenac sodium plus 3% menthol gel (in 30g aluminium tube). Dose given- 4g applied topically to a 400cm2 (20cm x 20cm) area of the skin, four times daily for three consecutive days with 5h between adjacent doses on the same day
arm group label: Diclofenac sodium/menthol gel (in roll-on device)
arm group type: Experimental
description: 1% diclofenac sodium plus 3% menthol gel (in roll-on applicator device supplied in 30g plastic bottles). Dose given- 4g applied topically to a 400cm2 (20cm x 20cm) area of the skin, four times daily for three consecutive days with 5h between adjacent doses on the same day
arm group label: Diclofenac sodium tablets
arm group type: Active Comparator
description: 50mg diclofenac sodium tablets administered orally, three times daily for three consecutive days with 6h between adjacent doses on the same day
arm group label: Voltaren gel
arm group type: Active Comparator
description: Voltaren gel supplied in 100g aluminium tube. Dose given- 4g applied topically to a 400cm2 (20cm x 20cm) area of the skin, four times daily for three consecutive days with 5h between adjacent doses on the same day
intervention type: Drug
intervention name: Diclofenac sodium
description: Diclofenac sodium
arm group label: Diclofenac sodium tablets
arm group label: Diclofenac sodium/menthol gel (in roll-on device)
arm group label: Diclofenac sodium/menthol gel (in tube)
arm group label: Voltaren gel
intervention type: Drug
intervention name: Menthol
description: Menthol
arm group label: Diclofenac sodium/menthol gel (in roll-on device)
arm group label: Diclofenac sodium/menthol gel (in tube)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diclofenac
mesh term: Menthol