<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/NCT03282838</url>
  </required_header>
  <id_info>
    <org_study_id>DFN-15-CD-008</org_study_id>
    <nct_id>NCT03282838</nct_id>
  </id_info>
  <brief_title>Study on the Pharmacokinetics (PK) of DFN-15 vs Comparator and Food-effect on DFN-15 PK in Healthy Adult Subjects</brief_title>
  <official_title>Open-Label, Three Way, Randomized, Single Dose Crossover Study Comparing Bioavailability of DFN-15 Oral Solution Under Fasting Conditions vs Comparator Under Fed Conditions and to Determine Food Effect of DFN-15 in Healthy Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Reddy's Laboratories Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dr. Reddy's Laboratories Limited</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      An Open-Label, Three-Way Randomized, Single Dose Crossover Study Comparing Bioavailability of&#xD;
      DFN-15 under fasting conditions versus Comparator under fed conditions and to determine&#xD;
      food-effect of DFN-15 in Healthy Adult Subjects&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 9, 2017</start_date>
  <completion_date type="Actual">January 12, 2018</completion_date>
  <primary_completion_date type="Actual">August 22, 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>DFN-15 maximum plasma concentration (Cmax)</measure>
    <time_frame>Up to 72 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>DFN-15 area under the curve (AUC) 0-t</measure>
    <time_frame>Up to 72 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>DFN-15 area under the curve (AUC) 0-inf</measure>
    <time_frame>Up to 72 hours</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Migraine</condition>
  <arm_group>
    <arm_group_label>DFN-15 (fasted)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>DFN-15 (fed)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator (fed)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DFN-15 (fasted)</intervention_name>
    <description>DFN-15 administered to fasted subjects</description>
    <arm_group_label>DFN-15 (fasted)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DFN-15 (fed)</intervention_name>
    <description>DFN-15 administered to fed subjects</description>
    <arm_group_label>DFN-15 (fed)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Comparator Celebrex® (fed)</intervention_name>
    <description>Comparator (Celebrex®) administered to fed subjects</description>
    <arm_group_label>Comparator (fed)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy, adult, male or female 19-55 years of age, inclusive, at screening.&#xD;
&#xD;
          -  Medically healthy with no clinically significant medical history, physical&#xD;
             examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or&#xD;
             designee.&#xD;
&#xD;
          -  Females of childbearing potential: must either be sexually inactive (abstinent) for 30&#xD;
             days prior to the first dose and throughout the study or be using birth control&#xD;
             method; Female subjects of non-childbearing potential and must have undergone&#xD;
             sterilization procedures or be postmenopausal for at least 1 year prior&#xD;
&#xD;
          -  Male subject must agree to use contraception or abstain during the study until 90 days&#xD;
             beyond the last dose of study drug.&#xD;
&#xD;
          -  Understands the study procedures in the informed consent form (ICF), and willing and&#xD;
             able to comply with the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or presence of hypersensitivity or idiosyncratic reaction to celecoxib,&#xD;
             sulfonamides, aspirin or other NSAIDs or related compounds&#xD;
&#xD;
          -  History or presence of clinically significant medical or psychiatric condition or&#xD;
             disease&#xD;
&#xD;
          -  History of any illness that, in the opinion of the PI or designee, might confound the&#xD;
             results of the study or poses an additional risk to the subject by their participation&#xD;
             in the study&#xD;
&#xD;
          -  liver enzyme tests greater than the upper limit of normal at screening&#xD;
&#xD;
          -  Estimated creatinine clearance &lt;90 mL/minute at screening&#xD;
&#xD;
          -  History or presence of alcoholism&#xD;
&#xD;
          -  History or presence of bilateral pedal edema or generalized edema or fluid retention&#xD;
&#xD;
          -  Female subjects who are pregnant or lactating or actively trying to conceive&#xD;
&#xD;
          -  Positive urine drug or alcohol results at screening or check-in&#xD;
&#xD;
          -  Positive cotinine at screening&#xD;
&#xD;
          -  Positive results at screening for human immunodeficiency virus (HIV), hepatitis B&#xD;
             surface antigen (HBsAg), or hepatitis C virus (HCV)&#xD;
&#xD;
          -  Seated blood pressure is less than 90/60 mmHg or greater than 140/90 mmHg at screening&#xD;
&#xD;
          -  Seated heart rate is lower than 45 bpm or higher than 100 bpm at screening&#xD;
&#xD;
          -  Has been on a diet incompatible with the on-study diet&#xD;
&#xD;
          -  Unable to refrain from or anticipates the use of prohibited medications&#xD;
&#xD;
          -  Donation of blood or significant blood loss within 56 days prior to the first dose of&#xD;
             study drug; plasma donation within 7 days prior to the first dose of study drug&#xD;
&#xD;
          -  Participation in another clinical trial within 28 days prior to the first dose of&#xD;
             study drug&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Celerion</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>February 10, 2018</last_update_submitted>
  <last_update_submitted_qc>February 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2018</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>Celecoxib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03282838
org study id: DFN-15-CD-008
nct id: NCT03282838
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
An Open-Label, Three-Way Randomized, Single Dose Crossover Study Comparing Bioavailability of
      DFN-15 under fasting conditions versus Comparator under fed conditions and to determine
      food-effect of DFN-15 in Healthy Adult Subjects
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: DFN-15 maximum plasma concentration (Cmax)
time frame: Up to 72 hours
measure: DFN-15 area under the curve (AUC) 0-t
time frame: Up to 72 hours
measure: DFN-15 area under the curve (AUC) 0-inf
time frame: Up to 72 hours
arm group label: DFN-15 (fasted)
arm group type: Experimental
arm group label: DFN-15 (fed)
arm group type: Experimental
arm group label: Comparator (fed)
arm group type: Experimental
intervention type: Drug
intervention name: DFN-15 (fasted)
description: DFN-15 administered to fasted subjects
arm group label: DFN-15 (fasted)
intervention type: Drug
intervention name: DFN-15 (fed)
description: DFN-15 administered to fed subjects
arm group label: DFN-15 (fed)
intervention type: Drug
intervention name: Comparator Celebrex® (fed)
description: Comparator (Celebrex®) administered to fed subjects
arm group label: Comparator (fed)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Celecoxib
sharing ipd: Undecided