<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/NCT02974361</url>
  </required_header>
  <id_info>
    <org_study_id>OAT-01</org_study_id>
    <nct_id>NCT02974361</nct_id>
  </id_info>
  <brief_title>Impact of Excipients on Pharmacokinetics of OXPzero(TM) Ibuprofen</brief_title>
  <official_title>An Open-label, Single-dose, Randomised, Crossover Study to Evaluate Changes in the Pharmacokinetics of Ibuprofen From Ibuprofen-LDH Dosed With and Without Release Modifying Excipients in Normal, Healthy, Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oxford Pharmascience Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oxford Pharmascience Ltd</source>
  <brief_summary>
    <textblock>
      This study is to help development of a new version of Ibuprofen, called Ibuprofen-LDH.&#xD;
      Ibuprofen-LDH will be used as a treatment for muscular pains, headache, fever etc. This new&#xD;
      version of ibuprofen is expected to produce fewer stomach/intestine related side effects when&#xD;
      compared to many existing marketed formulations of Ibuprofen.&#xD;
&#xD;
      This study is split into 3 parts. Part A is a 7 way crossover, Part B is a maximum of a 6 way&#xD;
      crossover and Part C is a maximum of a 4 way crossover. The size of Parts B &amp; Part C and&#xD;
      allocated interventions will be confirmed after review of data from Parts A and/or B&#xD;
      respectively.&#xD;
&#xD;
      A total of 30 subjects will take part in the study; 10 per study part.&#xD;
&#xD;
      The key objective is to assess the pharmacokinetics properties of Ibuprofen-LDH, with and&#xD;
      without a selection of different excipients. The pharmacokinetic properties will include how&#xD;
      quickly the drug is absorbed into the bloodstream and also the maximum concentration of drug&#xD;
      that reaches the bloodstream.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">May 3, 2017</completion_date>
  <primary_completion_date type="Actual">April 28, 2017</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>12 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC(0-inf)</measure>
    <time_frame>12 hours</time_frame>
  </primary_outcome>
  <number_of_arms>17</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Pharmacokinetics</condition>
  <arm_group>
    <arm_group_label>Part A Ibuprofen control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A Ibuprofen-LDH</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A Ibuprofen-LDH Excipient Combo 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A Ibuprofen-LDH Excipient Combo 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A Ibuprofen-LDH Excipient Combo 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A Ibuprofen-LDH Excipient Combo 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A Ibuprofen Lysine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B Ibuprofen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B Ibuprofen LDH Excipient Combo 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B Ibuprofen LDH Excipient Combo 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B Ibuprofen LDH Excipient Combo 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B Ibuprofen LDH Excipient Combo 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part C Ibuprofen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part C Ibuprofen LDH Excipient Combo 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part C Ibuprofen LDH Excipient Combo 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part C Ibuprofen LDH Excipient Combo 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B Ibuprofen LDH Excipient Combo 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen</intervention_name>
    <arm_group_label>Part A Ibuprofen control</arm_group_label>
    <arm_group_label>Part B Ibuprofen</arm_group_label>
    <arm_group_label>Part C Ibuprofen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen Lysine</intervention_name>
    <arm_group_label>Part A Ibuprofen Lysine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen-LDH</intervention_name>
    <arm_group_label>Part A Ibuprofen-LDH</arm_group_label>
    <arm_group_label>Part A Ibuprofen-LDH Excipient Combo 1</arm_group_label>
    <arm_group_label>Part A Ibuprofen-LDH Excipient Combo 2</arm_group_label>
    <arm_group_label>Part A Ibuprofen-LDH Excipient Combo 3</arm_group_label>
    <arm_group_label>Part A Ibuprofen-LDH Excipient Combo 4</arm_group_label>
    <arm_group_label>Part B Ibuprofen LDH Excipient Combo 1</arm_group_label>
    <arm_group_label>Part B Ibuprofen LDH Excipient Combo 2</arm_group_label>
    <arm_group_label>Part B Ibuprofen LDH Excipient Combo 3</arm_group_label>
    <arm_group_label>Part B Ibuprofen LDH Excipient Combo 4</arm_group_label>
    <arm_group_label>Part B Ibuprofen LDH Excipient Combo 5</arm_group_label>
    <arm_group_label>Part C Ibuprofen LDH Excipient Combo 1</arm_group_label>
    <arm_group_label>Part C Ibuprofen LDH Excipient Combo 2</arm_group_label>
    <arm_group_label>Part C Ibuprofen LDH Excipient Combo 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female subjects&#xD;
&#xD;
          -  BMI 18 - 30 kg/m2&#xD;
&#xD;
          -  Willing and able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence or history of significant renal, hepatic, gastrointestinal, central nervous&#xD;
             system, respiratory, cardiovascular, autoimmune or metabolic dysfunction&#xD;
&#xD;
          -  Recent or concurrent use of prescription or non-prescription medications, other than&#xD;
             contraceptives&#xD;
&#xD;
          -  Allergy or sensitivity to NSAIDs&#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>Annelize Koch</last_name>
    <role>Principal Investigator</role>
    <affiliation>Simbec Orion Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Simbec Orion Ltd</name>
      <address>
        <city>Merthyr Tydfil</city>
        <zip>CF48 4DR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>May 2, 2017</last_update_submitted>
  <last_update_submitted_qc>May 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 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>Ibuprofen</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/NCT02974361
org study id: OAT-01
nct id: NCT02974361
lead sponsor: 
This study is to help development of a new version of Ibuprofen, called Ibuprofen-LDH.
      Ibuprofen-LDH will be used as a treatment for muscular pains, headache, fever etc. This new
      version of ibuprofen is expected to produce fewer stomach/intestine related side effects when
      compared to many existing marketed formulations of Ibuprofen.

      This study is split into 3 parts. Part A is a 7 way crossover, Part B is a maximum of a 6 way
      crossover and Part C is a maximum of a 4 way crossover. The size of Parts B & Part C and
      allocated interventions will be confirmed after review of data from Parts A and/or B
      respectively.

      A total of 30 subjects will take part in the study; 10 per study part.

      The key objective is to assess the pharmacokinetics properties of Ibuprofen-LDH, with and
      without a selection of different excipients. The pharmacokinetic properties will include how
      quickly the drug is absorbed into the bloodstream and also the maximum concentration of drug
      that reaches the bloodstream.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Cmax
time frame: 12 hours
measure: AUC(0-inf)
time frame: 12 hours
arm group label: Part A Ibuprofen control
arm group type: Active Comparator
arm group label: Part A Ibuprofen-LDH
arm group type: Experimental
arm group label: Part A Ibuprofen-LDH Excipient Combo 1
arm group type: Experimental
arm group label: Part A Ibuprofen-LDH Excipient Combo 2
arm group type: Experimental
arm group label: Part A Ibuprofen-LDH Excipient Combo 3
arm group type: Experimental
arm group label: Part A Ibuprofen-LDH Excipient Combo 4
arm group type: Experimental
arm group label: Part A Ibuprofen Lysine
arm group type: Active Comparator
arm group label: Part B Ibuprofen
arm group type: Active Comparator
arm group label: Part B Ibuprofen LDH Excipient Combo 1
arm group type: Experimental
arm group label: Part B Ibuprofen LDH Excipient Combo 2
arm group type: Experimental
arm group label: Part B Ibuprofen LDH Excipient Combo 3
arm group type: Experimental
arm group label: Part B Ibuprofen LDH Excipient Combo 4
arm group type: Experimental
arm group label: Part C Ibuprofen
arm group type: Active Comparator
arm group label: Part C Ibuprofen LDH Excipient Combo 1
arm group type: Experimental
arm group label: Part C Ibuprofen LDH Excipient Combo 2
arm group type: Experimental
arm group label: Part C Ibuprofen LDH Excipient Combo 3
arm group type: Experimental
arm group label: Part B Ibuprofen LDH Excipient Combo 5
arm group type: Experimental
intervention type: Drug
intervention name: Ibuprofen
arm group label: Part A Ibuprofen control
arm group label: Part B Ibuprofen
arm group label: Part C Ibuprofen
intervention type: Drug
intervention name: Ibuprofen Lysine
arm group label: Part A Ibuprofen Lysine
intervention type: Drug
intervention name: Ibuprofen-LDH
arm group label: Part A Ibuprofen-LDH
arm group label: Part A Ibuprofen-LDH Excipient Combo 1
arm group label: Part A Ibuprofen-LDH Excipient Combo 2
arm group label: Part A Ibuprofen-LDH Excipient Combo 3
arm group label: Part A Ibuprofen-LDH Excipient Combo 4
arm group label: Part B Ibuprofen LDH Excipient Combo 1
arm group label: Part B Ibuprofen LDH Excipient Combo 2
arm group label: Part B Ibuprofen LDH Excipient Combo 3
arm group label: Part B Ibuprofen LDH Excipient Combo 4
arm group label: Part B Ibuprofen LDH Excipient Combo 5
arm group label: Part C Ibuprofen LDH Excipient Combo 1
arm group label: Part C Ibuprofen LDH Excipient Combo 2
arm group label: Part C Ibuprofen LDH Excipient Combo 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Annelize Koch
role: Principal Investigator
affiliation: Simbec Orion Ltd
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Ibuprofen