<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/NCT01677065</url>
  </required_header>
  <id_info>
    <org_study_id>B4531007</org_study_id>
    <secondary_id>ALO-02 Bioavailability Study</secondary_id>
    <nct_id>NCT01677065</nct_id>
  </id_info>
  <brief_title>A Randomized, Two-way, Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers</brief_title>
  <official_title>An Open-label, Single-dose, Randomized, Two-way Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine whether the bioavailability of the controlled-release test formulation is at&#xD;
      least as high as that for the commercial reference drug.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Serial sampling of venous blood&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>pharmacokinetic endpoints - area under the concentration curve (AUC)</measure>
    <time_frame>0-48 hr</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peak concentration (Cmax) and time to peak concentration (Tmax)</measure>
    <time_frame>0-48 hr</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">14</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Treatment A</arm_group_label>
    <description>Controlled release oxycodone test formulation 40 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment B</arm_group_label>
    <description>Immediate release oxycodone reference drug 20 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxycodone controlled-release test formulation</intervention_name>
    <description>single dose administration of test formulation under fasted conditions</description>
    <arm_group_label>Treatment A</arm_group_label>
    <other_name>ALO-02</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Immediate-release reference drug</intervention_name>
    <description>single dose administration of reference drug under fasted conditions</description>
    <arm_group_label>Treatment B</arm_group_label>
    <other_name>Roxicodone</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy adult volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy volunteers, greater than 50 kg, able and willing to sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of significant illness, condition affecting drug absorption, history of sleep&#xD;
             apnea, and allergy to opioid drugs&#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>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pfizer Investigational Site</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B4531007</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>September 26, 2018</last_update_submitted>
  <last_update_submitted_qc>September 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bioavailability</keyword>
  <keyword>Oxycodone</keyword>
  <keyword>Healthy Volunteers</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxycodone</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/NCT01677065
org study id: B4531007
secondary id: ALO-02 Bioavailability Study
nct id: NCT01677065
lead sponsor: 
has dmc: No
To determine whether the bioavailability of the controlled-release test formulation is at
      least as high as that for the commercial reference drug.
Serial sampling of venous blood
observational model: Case-Crossover
time perspective: Prospective
measure: pharmacokinetic endpoints - area under the concentration curve (AUC)
time frame: 0-48 hr
measure: Peak concentration (Cmax) and time to peak concentration (Tmax)
time frame: 0-48 hr
arm group label: Treatment A
description: Controlled release oxycodone test formulation 40 mg
arm group label: Treatment B
description: Immediate release oxycodone reference drug 20 mg
intervention type: Drug
intervention name: Oxycodone controlled-release test formulation
description: single dose administration of test formulation under fasted conditions
arm group label: Treatment A
other name: ALO-02
intervention type: Drug
intervention name: Immediate-release reference drug
description: single dose administration of reference drug under fasted conditions
arm group label: Treatment B
other name: Roxicodone
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
country: United States
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B4531007
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Oxycodone