<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/NCT02991222</url>
  </required_header>
  <id_info>
    <org_study_id>CLR_16_28</org_study_id>
    <nct_id>NCT02991222</nct_id>
  </id_info>
  <brief_title>Bioavailability Study of SPARC001(Study 1) in Healthy Adult Volunteers</brief_title>
  <official_title>A Randomized, Open-Label, Single-Dose Bioavailability Study of SPARC001 in Healthy, Adult Volunteers Under Fed and Fasted Conditions&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Pharma Advanced Research Company Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Pharma Advanced Research Company Limited</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to determine the relative bioavailability, safety and&#xD;
      tolerability of SPARC001 and Reference001 in healthy, adult, male and female subjects&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2017</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">February 15, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC</measure>
    <time_frame>48 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>48 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse event</measure>
    <time_frame>25 days</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>SPARC001 type I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment type I</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SPARC001 type II</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment type II</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reference001 type I</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment type I</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reference type II</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment type II</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SPARC001 type I</intervention_name>
    <description>Treatment type I</description>
    <arm_group_label>Reference type II</arm_group_label>
    <arm_group_label>Reference001 type I</arm_group_label>
    <arm_group_label>SPARC001 type I</arm_group_label>
    <arm_group_label>SPARC001 type II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SPARC001 type II</intervention_name>
    <description>Treatment type II</description>
    <arm_group_label>Reference type II</arm_group_label>
    <arm_group_label>Reference001 type I</arm_group_label>
    <arm_group_label>SPARC001 type I</arm_group_label>
    <arm_group_label>SPARC001 type II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Reference001 type I</intervention_name>
    <description>Hydrocodone-Acetaminophen</description>
    <arm_group_label>Reference type II</arm_group_label>
    <arm_group_label>Reference001 type I</arm_group_label>
    <arm_group_label>SPARC001 type I</arm_group_label>
    <arm_group_label>SPARC001 type II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Reference001 type II</intervention_name>
    <description>Hydrocodone-Acetaminophen</description>
    <arm_group_label>Reference type II</arm_group_label>
    <arm_group_label>Reference001 type I</arm_group_label>
    <arm_group_label>SPARC001 type I</arm_group_label>
    <arm_group_label>SPARC001 type II</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult, male and female volunteers, 18 to 55 years of age, inclusive, at first Check-In&#xD;
             Visit;&#xD;
&#xD;
          2. Body mass index (BMI) ≥18 to ≤30 kg/m2 and total body weight &gt;50 kg (110 lbs) at&#xD;
             Screening&#xD;
&#xD;
          3. All female subjects must have a negative serum pregnancy test at Screening and at each&#xD;
             Check-in Visit&#xD;
&#xD;
          4. Medically healthy on the basis of medical history&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Females who are pregnant, lactating, or likely to become pregnant during the study&#xD;
&#xD;
          2. Life-time history and/or recent evidence of alcohol or drug/substance abuse disorder&#xD;
&#xD;
          3. Subjects with history or presence of significant cardiovascular, pulmonary, hepatic,&#xD;
             gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine,&#xD;
             immunologic, dermatologic, neurologic, psychiatric disease, or active sexually&#xD;
             transmitted disease&#xD;
&#xD;
          4. Subjects determined by the investigator to have any medical condition that could&#xD;
             jeopardize their health or prejudice the results&#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>
  <location>
    <facility>
      <name>SPARC Site 01</name>
      <address>
        <city>Secaucus</city>
        <state>New Jersey</state>
        <zip>07094</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>May 2, 2019</last_update_submitted>
  <last_update_submitted_qc>May 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02991222
org study id: CLR_16_28
nct id: NCT02991222
lead sponsor: 
has dmc: No
The objective of the study is to determine the relative bioavailability, safety and
      tolerability of SPARC001 and Reference001 in healthy, adult, male and female subjects
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC
time frame: 48 hours
measure: Cmax
time frame: 48 hours
measure: Adverse event
time frame: 25 days
arm group label: SPARC001 type I
arm group type: Experimental
description: Treatment type I
arm group label: SPARC001 type II
arm group type: Experimental
description: Treatment type II
arm group label: Reference001 type I
arm group type: Active Comparator
description: Treatment type I
arm group label: Reference type II
arm group type: Active Comparator
description: Treatment type II
intervention type: Drug
intervention name: SPARC001 type I
description: Treatment type I
arm group label: Reference type II
arm group label: Reference001 type I
arm group label: SPARC001 type I
arm group label: SPARC001 type II
intervention type: Drug
intervention name: SPARC001 type II
description: Treatment type II
arm group label: Reference type II
arm group label: Reference001 type I
arm group label: SPARC001 type I
arm group label: SPARC001 type II
intervention type: Drug
intervention name: Reference001 type I
description: Hydrocodone-Acetaminophen
arm group label: Reference type II
arm group label: Reference001 type I
arm group label: SPARC001 type I
arm group label: SPARC001 type II
intervention type: Drug
intervention name: Reference001 type II
description: Hydrocodone-Acetaminophen
arm group label: Reference type II
arm group label: Reference001 type I
arm group label: SPARC001 type I
arm group label: SPARC001 type II
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor