<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/NCT02259179</url>
  </required_header>
  <id_info>
    <org_study_id>NB-240</org_study_id>
    <nct_id>NCT02259179</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study Comparing Naltrexone SR/Bupropion SR Trilayer Tablets From Two Manufacturers</brief_title>
  <official_title>A Phase 1 Bioequivalence Study of Naltrexone SR/Bupropion SR Combination Trilayer Tablets From Two Manufacturers in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Orexigen Therapeutics, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Orexigen Therapeutics, Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 1, open-label, randomized, single-dose, 2-way crossover study in healthy&#xD;
      adult subjects to assess the bioequivalence of naltrexone SR/bupropion SR combination&#xD;
      trilayer tablets prepared at two different manufacturing sites. The pharmacokinetics of the&#xD;
      two drug products will be evaluated separately in the fed and fasted state.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>0-96 hours post-dose</time_frame>
    <description>Maximum observed plasma concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC(0-t)</measure>
    <time_frame>0-96 hours post-dose</time_frame>
    <description>Area under the plasma concentration-time curve from 0 hour to the time of the last quantifiable concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC(0-inf)</measure>
    <time_frame>0-96 hours post-dose</time_frame>
    <description>Area under the plasma concentration-time curve from 0 hour extrapolated to infinity</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Fed Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Reference and test product naltrexone SR/bupropion SR combination trilayer tablets tested in the fed state.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fasted group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Reference and test product naltrexone SR/bupropion SR combination trilayer tablets tested in the fasted state.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Reference naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets)</intervention_name>
    <arm_group_label>Fasted group</arm_group_label>
    <arm_group_label>Fed Group</arm_group_label>
    <other_name>Contrave</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Test naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets)</intervention_name>
    <arm_group_label>Fasted group</arm_group_label>
    <arm_group_label>Fed Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female, 18 to 60 years of age, inclusive&#xD;
&#xD;
          2. Be in good general health, without any clinically significant medical history,&#xD;
             physical examination findings, or laboratory results at Screening or Day -1&#xD;
&#xD;
          3. Body mass index (BMI) of 18 to 30 kg/m2, inclusive, at Screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Acute (within 28 days of Day -1) or chronic illness&#xD;
&#xD;
          2. History (within the last 20 years) of seizures, cranial trauma, bulimia, anorexia&#xD;
             nervosa, or other conditions that may predispose the subject to seizures; or previous&#xD;
             medical treatment with anticonvulsants of any type&#xD;
&#xD;
          3. History of mania or current diagnosis of active psychosis&#xD;
&#xD;
          4. Acute depressive illness, including new onset of depression or acute exacerbation of&#xD;
             symptoms&#xD;
&#xD;
          5. Use of any prescription medication within 14 days prior to Day -1, with the exception&#xD;
             of hormonal contraceptive or hormonal replacement therapy (HRT) at a stable dose for&#xD;
             at least 28 days prior to Day -1&#xD;
&#xD;
          6. Use of any over-the-counter medications, including dietary/nutritional and herbal&#xD;
             supplements, within 24 hours prior to study drug intake on Day 1&#xD;
&#xD;
          7. Use of bupropion- or naltrexone-containing products within 28 days prior to Day -1, or&#xD;
             history of hypersensitivity or intolerance to naltrexone or bupropion&#xD;
&#xD;
          8. Have donated blood or have had significant blood loss within 90 days prior to Day -1;&#xD;
             or have donated plasma within 7 days prior to Day -1&#xD;
&#xD;
          9. Hemoglobin concentration &lt;11 g/dL at Screening&#xD;
&#xD;
         10. Blood pressure &gt;140/90 mm Hg at Screening or Day -1&#xD;
&#xD;
         11. Women who are pregnant or trying to become pregnant, have a positive pregnancy test at&#xD;
             Screening or Day -1, are currently breast-feeding, or are of childbearing potential&#xD;
             (including perimenopausal women who have had a menstrual period within 1 year prior to&#xD;
             Day -1) and are not willing to practice effective birth control. Women who are&#xD;
             surgically sterile (including bilateral tubal ligation, tubal occlusion, hysterectomy&#xD;
             or oophorectomy) are not considered to be of childbearing potential.&#xD;
&#xD;
         12. Drug or alcohol abuse or dependence within 6 months prior to Screening, or positive&#xD;
             urine drug screen at Screening or Day -1&#xD;
&#xD;
         13. Regular daily use of tobacco products, including inhaled tobacco (e.g., cigarettes,&#xD;
             cigars, pipes), chewing tobacco or snuff, or nicotine replacement products (including&#xD;
             electronic cigarettes or nicotine vaporizers) within 28 days prior to Day -1&#xD;
&#xD;
         14. Unwilling to refrain from consumption of any citrus products (e.g., whole fruit, juice&#xD;
             or products containing orange, grapefruit, or pomelo), alcohol or&#xD;
             caffeine/xanthine-containing foods or beverages for 48 hours before study drug intake&#xD;
             in each treatment period (Days 1 and 15) until 72 hours postdose (Days 4 and 18)&#xD;
&#xD;
         15. Inability or unwillingness to consume a standardized high-fat breakfast as provided at&#xD;
             the study clinic on Days 1 and 15&#xD;
&#xD;
         16. Inability to comply with all required study procedures and schedule, inability to&#xD;
             speak and read English, or unwillingness or inability to give written informed consent&#xD;
&#xD;
         17. Employee or immediate family member of the sponsor (or designee) or study site&#xD;
             research staff&#xD;
&#xD;
         18. Use of any investigational drug, device, or procedure within 30 days prior to Day -1&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Senior Vice President Head of Global Development</last_name>
    <role>Study Director</role>
    <affiliation>Orexigen Therapeutics, Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Quintiles Phase One Services, LLC</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>December 10, 2014</last_update_submitted>
  <last_update_submitted_qc>December 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Overweight</keyword>
  <keyword>Contrave</keyword>
  <keyword>Antiobesity agents</keyword>
  <keyword>Antiobesity drugs</keyword>
  <keyword>Weight loss drug</keyword>
  <keyword>Bioequivalence</keyword>
  <keyword>Pharmacokinetic</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Naltrexone</mesh_term>
    <mesh_term>Bupropion</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/NCT02259179
org study id: NB-240
nct id: NCT02259179
lead sponsor: 
has dmc: No
This is a Phase 1, open-label, randomized, single-dose, 2-way crossover study in healthy
      adult subjects to assess the bioequivalence of naltrexone SR/bupropion SR combination
      trilayer tablets prepared at two different manufacturing sites. The pharmacokinetics of the
      two drug products will be evaluated separately in the fed and fasted state.
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Cmax
time frame: 0-96 hours post-dose
description: Maximum observed plasma concentration
measure: AUC(0-t)
time frame: 0-96 hours post-dose
description: Area under the plasma concentration-time curve from 0 hour to the time of the last quantifiable concentration
measure: AUC(0-inf)
time frame: 0-96 hours post-dose
description: Area under the plasma concentration-time curve from 0 hour extrapolated to infinity
arm group label: Fed Group
arm group type: Active Comparator
description: Reference and test product naltrexone SR/bupropion SR combination trilayer tablets tested in the fed state.
arm group label: Fasted group
arm group type: Active Comparator
description: Reference and test product naltrexone SR/bupropion SR combination trilayer tablets tested in the fasted state.
intervention type: Drug
intervention name: Reference naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets)
arm group label: Fasted group
arm group label: Fed Group
other name: Contrave
intervention type: Drug
intervention name: Test naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets)
arm group label: Fasted group
arm group label: Fed Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Senior Vice President Head of Global Development
role: Study Director
affiliation: Orexigen Therapeutics, Inc
facility: 
country: United States
responsible party type: Sponsor
mesh term: Naltrexone
mesh term: Bupropion