<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/NCT03794154</url>
  </required_header>
  <id_info>
    <org_study_id>B2781005</org_study_id>
    <nct_id>NCT03794154</nct_id>
  </id_info>
  <brief_title>A Study Of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta Under Fed Conditions</brief_title>
  <official_title>A PHASE IV, SINGLE-DOSE, OPEN-LABEL, RANDOMIZED, 2-WAY CROSSOVER STUDY TO DETERMINE THE BIOEQUIVALENCE OF DULOXETINE HYDROCHLORIDE HARD GELATINOUS CAPSULE WITH DELAYED RELEASE MICROGRANULES (60 MG; PFIZER S.R.L - ARGENTINA.) COMPARED TO CYMBALTA (REGISTERED) MICROGRANULES (60 MG; ELI LILLY DO BRASIL LTDA) IN HEALTHY MALE RESEARCH SUBJECTS UNDER FED CONDITIONS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In Brazil, duloxetine is currently available as hard gelatinous capsule with delayed release&#xD;
      microgranules for oral administration containing enteric-coated pellets of 33.7, or 67.3 mg&#xD;
      of duloxetine hydrochloride equivalent to 30 mg or 60 mg of duloxetine (Cymbalta®),&#xD;
      respectively.&#xD;
&#xD;
      The Sponsor has developed a hard gelatinous capsule with delayed release microgranules&#xD;
      formulation containing enteric-coated pellets of 33.7, or 67.3 mg of duloxetine hydrochloride&#xD;
      equivalent to 30, or 60 mg of duloxetine, respectively.&#xD;
&#xD;
      The purpose of this study is to verify through a single dose study, if the test formulation&#xD;
      of duloxetine is bioequivalent to the reference formulation (Cymbalta®) when administered&#xD;
      with the same dosage and under fed conditions in healthy male research subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    This study has been cancelled prior to FSFV due to business reasons&#xD;
  </why_stopped>
  <start_date type="Anticipated">March 30, 2020</start_date>
  <completion_date type="Anticipated">June 5, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 5, 2020</primary_completion_date>
  <phase>Phase 4</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>Area under the plasma concentration-time curve</measure>
    <time_frame>Upto 72 hours post dose</time_frame>
    <description>Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum plasma concentration (Cmax)</measure>
    <time_frame>Upto 72 hours post dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve from time zero extrapolated to infinite time</measure>
    <time_frame>Upto 72 hours post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first occurrence of Cmax (Tmax)</measure>
    <time_frame>Upto 72 hours post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal phase rate constant (kel)</measure>
    <time_frame>Upto 72 hours post dose</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Duloxetine hydrochloride</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Duloxetine hydrochloride hard gelatinous capsule 60 mg by mouth on Day 1 of period 1 or 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cymbalta</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Duloxetine hydrochloride hard gelatinous capsule 60 mg as Cymbalta by mouth on Day 1 of period 1 or 2</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cymbalta capsule</intervention_name>
    <description>Active Comparator: Cymbalta®- hard gelatinous capsule with delayed release microgranules ( Eli Lilly do Brasil Ltda) equivalent to 60 mg of duloxetine.</description>
    <arm_group_label>Cymbalta</arm_group_label>
    <other_name>Reference drug</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Duloxetine hydrochloride capsule</intervention_name>
    <description>Experimental Drug: Duloxetine hydrochloride - hard gelatinous capsule with delayed release microgranules (Pfizer S.R.L - Argentina.) equivalent to 60 mg of duloxetine.</description>
    <arm_group_label>Duloxetine hydrochloride</arm_group_label>
    <other_name>Test drug</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male research subjects who, at the time of screening, are between the ages of&#xD;
             18 and 55 years, inclusive.&#xD;
&#xD;
          -  Body mass index (BMI) of 18.5 kg/m2 to 24.9 kg/m2, and a total body weight &gt;50 kg&#xD;
             (&gt;110 lbs).&#xD;
&#xD;
          -  Evidence of a personally signed and dated informed consent document indicating that&#xD;
             the research subject has been informed of all pertinent aspects of the study.&#xD;
&#xD;
          -  Research subjects that never smoked.&#xD;
&#xD;
          -  Research subjects who are willing and able to comply with all scheduled visits,&#xD;
             treatment plan, laboratory tests, and other study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence or history of clinically significant hematological, renal, endocrine,&#xD;
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or&#xD;
             allergic disease.&#xD;
&#xD;
          -  Clinically significant infections within the past 3 months, evidence of any infection&#xD;
             within the past 7 days, history of disseminated herpes simplex infection or recurrent&#xD;
             (&gt;1 episode) or disseminated herpes zoster.&#xD;
&#xD;
          -  Vaccination with live or attenuated vaccines within 6 weeks prior to dosing.&#xD;
&#xD;
          -  A history of suicidal thoughts, behavior or suicide attempts.&#xD;
&#xD;
          -  History of narrow angle glaucoma.&#xD;
&#xD;
          -  Any condition possibly affecting drug absorption (eg, gastrectomy, colon resection,&#xD;
             etc.).&#xD;
&#xD;
          -  History of or current positive results for any of the following serological tests:&#xD;
             hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), anti hepatitis&#xD;
             C core antibody (HCV Ab), or human immunodeficiency virus (HIV) 1 and 2.&#xD;
&#xD;
          -  Malignancy or a history of malignancy.&#xD;
&#xD;
          -  A positive urine drug test.&#xD;
&#xD;
          -  A positive alcohol screen.&#xD;
&#xD;
          -  History of regular alcohol consumption exceeding 21 drinks/week for male research&#xD;
             subjects [1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5&#xD;
             ounces (45 mL) of hard liquor] within 6 months before screening.&#xD;
&#xD;
          -  Use of tobacco or all nicotine containing products.&#xD;
&#xD;
          -  Treatment with an investigational drug within 6 months or 5 half lives preceding the&#xD;
             first dose of investigational product (whichever is longer).&#xD;
&#xD;
          -  Fertile male subjects who are unwilling or unable to use a highly effective method of&#xD;
             contraception as outlined in this protocol for the duration of the study and for at&#xD;
             least 28 days after the last dose of investigational product.&#xD;
&#xD;
          -  Use of prescription or nonprescription drugs and dietary supplements within 14 days or&#xD;
             5 half lives (whichever is longer) prior to the first dose of investigational product.&#xD;
&#xD;
          -  Consumption of grapefruit or grapefruit related citrus fruits (eg, Seville oranges,&#xD;
             pomelos) or juices within 7 days prior to dosing.&#xD;
&#xD;
          -  Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more&#xD;
             within 3 months prior to screening until collection of the final PK blood sample&#xD;
             (Period 2, Day 4).&#xD;
&#xD;
          -  History of sensitivity to heparin or heparin induced thrombocytopenia.&#xD;
&#xD;
          -  History of hypersensitivity to duloxetine or any of the components in the formulation&#xD;
             of the study products.&#xD;
&#xD;
          -  Unwilling or unable to comply with the criteria in the Lifestyle Requirements section&#xD;
             of this protocol.&#xD;
&#xD;
          -  Use of any medicinal product that is an inductor or strong inhibitor of CYP450 1A2 or&#xD;
             2D6 (eg, rifampicin, omeprazole, fluvoxamine, ciprofloxacin, fluoxetine, paroxetine,&#xD;
             etc) within two weeks before administration of the investigational product and at any&#xD;
             time during the study.&#xD;
&#xD;
          -  Use of any medicinal product that inhibits monoamine oxidase A or B (eg, phenelzine,&#xD;
             isocarboxacid, linezolid) within two weeks before administration of the&#xD;
             investigational product and at any time during the study till at least 5 days after&#xD;
             the last dose of investigational product.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <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>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2781005&amp;StudyName=A+Phase+Iv%2C+Single-dose%2C+Open-label%2C+Randomized%2C+2-way+Crossover+Study+To+Determine+The+Bioequivalence+Of+Duloxetine+Hydrochloride+Hard+Gelatinous+Capsule+With+Delayed+Release+Microgranules+%2860+Mg%3B+Pfizer+S.r.l+-+Argentina.%29+Compared+To+Cymbalta+%28registered%29%EF%83%92microgranules+%2860+Mg%3B+Eli+Lilly+Do+Brasil+Ltda%29+In+Healthy+Male+Research+Subjects+Under+Fed+Conditions</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2781005&amp;StudyName=A+Phase+Iv%2C+Single-dose%2C+Open-label%2C+Randomized%2C+2-way+Crossover+Study+To+Determine+The+Bioequivalence+Of+Duloxetine+Hydrochloride+Hard+Gelatinous+Capsule+With+Delayed+Release+Microgranules+%2860+Mg%3B+Pfizer+S.r.l+-+Argentina.%29+Compared+To+Cymbalta+%28registered%29+Microgranules+%2860+Mg%3B+Eli+Lilly+Do+Brasil+Ltda%29+In+Healthy+Male+Research+Subjects+Under+Fed+Conditions</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2781005&amp;StudyName=A+PHASE+IV%2C+SINGLE-DOSE%2C+OPEN-LABEL%2C+RANDOMIZED%2C+2-WAY%0ACROSSOVER+STUDY+TO+DETERMINE+THE+BIOEQUIVALENCE+OF%0ADULOXETINE+HYDROCHLORIDE+HARD+GELATINOUS+CAPSULE+WITH%0ADELAYED+RELEASE+MICROGRANULES+%2860+MG%3B+PFIZER+S.R.L+-+ARGENTINA.%29+COMPARED+TO+CYMBALTA+%28REGISTERED%29+MICROGRANULES+%2860+MG%3B+ELI+LILLY+DO+BRASIL+LTDA%29+IN+HEALTHY+MALE+RESEARCH+SUBJECTS+UNDER+FED+CONDITIONS</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>September 25, 2019</last_update_submitted>
  <last_update_submitted_qc>September 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Duloxetine Hydrochloride</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
    <ipd_url>https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests</ipd_url>
  </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/NCT03794154
org study id: B2781005
nct id: NCT03794154
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In Brazil, duloxetine is currently available as hard gelatinous capsule with delayed release
      microgranules for oral administration containing enteric-coated pellets of 33.7, or 67.3 mg
      of duloxetine hydrochloride equivalent to 30 mg or 60 mg of duloxetine (Cymbalta®),
      respectively.

      The Sponsor has developed a hard gelatinous capsule with delayed release microgranules
      formulation containing enteric-coated pellets of 33.7, or 67.3 mg of duloxetine hydrochloride
      equivalent to 30, or 60 mg of duloxetine, respectively.

      The purpose of this study is to verify through a single dose study, if the test formulation
      of duloxetine is bioequivalent to the reference formulation (Cymbalta®) when administered
      with the same dosage and under fed conditions in healthy male research subjects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Area under the plasma concentration-time curve
time frame: Upto 72 hours post dose
description: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
measure: Maximum plasma concentration (Cmax)
time frame: Upto 72 hours post dose
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time
time frame: Upto 72 hours post dose
measure: Time to first occurrence of Cmax (Tmax)
time frame: Upto 72 hours post dose
measure: Terminal phase rate constant (kel)
time frame: Upto 72 hours post dose
arm group label: Duloxetine hydrochloride
arm group type: Experimental
description: Duloxetine hydrochloride hard gelatinous capsule 60 mg by mouth on Day 1 of period 1 or 2
arm group label: Cymbalta
arm group type: Active Comparator
description: Duloxetine hydrochloride hard gelatinous capsule 60 mg as Cymbalta by mouth on Day 1 of period 1 or 2
intervention type: Drug
intervention name: Cymbalta capsule
description: Active Comparator: Cymbalta®- hard gelatinous capsule with delayed release microgranules ( Eli Lilly do Brasil Ltda) equivalent to 60 mg of duloxetine.
arm group label: Cymbalta
other name: Reference drug
intervention type: Drug
intervention name: Duloxetine hydrochloride capsule
description: Experimental Drug: Duloxetine hydrochloride - hard gelatinous capsule with delayed release microgranules (Pfizer S.R.L - Argentina.) equivalent to 60 mg of duloxetine.
arm group label: Duloxetine hydrochloride
other name: Test drug
criteria: 
gender: Male
gender based: Yes
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
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2781005&StudyName=A+Phase+Iv%2C+Single-dose%2C+Open-label%2C+Randomized%2C+2-way+Crossover+Study+To+Determine+The+Bioequivalence+Of+Duloxetine+Hydrochloride+Hard+Gelatinous+Capsule+With+Delayed+Release+Microgranules+%2860+Mg%3B+Pfizer+S.r.l+-+Argentina.%29+Compared+To+Cymbalta+%28registered%29%EF%83%92microgranules+%2860+Mg%3B+Eli+Lilly+Do+Brasil+Ltda%29+In+Healthy+Male+Research+Subjects+Under+Fed+Conditions
description: To obtain contact information for a study center near you, click here.
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2781005&StudyName=A+Phase+Iv%2C+Single-dose%2C+Open-label%2C+Randomized%2C+2-way+Crossover+Study+To+Determine+The+Bioequivalence+Of+Duloxetine+Hydrochloride+Hard+Gelatinous+Capsule+With+Delayed+Release+Microgranules+%2860+Mg%3B+Pfizer+S.r.l+-+Argentina.%29+Compared+To+Cymbalta+%28registered%29+Microgranules+%2860+Mg%3B+Eli+Lilly+Do+Brasil+Ltda%29+In+Healthy+Male+Research+Subjects+Under+Fed+Conditions
description: To obtain contact information for a study center near you, click here.
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2781005&StudyName=A+PHASE+IV%2C+SINGLE-DOSE%2C+OPEN-LABEL%2C+RANDOMIZED%2C+2-WAY%0ACROSSOVER+STUDY+TO+DETERMINE+THE+BIOEQUIVALENCE+OF%0ADULOXETINE+HYDROCHLORIDE+HARD+GELATINOUS+CAPSULE+WITH%0ADELAYED+RELEASE+MICROGRANULES+%2860+MG%3B+PFIZER+S.R.L+-+ARGENTINA.%29+COMPARED+TO+CYMBALTA+%28REGISTERED%29+MICROGRANULES+%2860+MG%3B+ELI+LILLY+DO+BRASIL+LTDA%29+IN+HEALTHY+MALE+RESEARCH+SUBJECTS+UNDER+FED+CONDITIONS
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Malnutrition
mesh term: Duloxetine Hydrochloride
sharing ipd: Yes
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
ipd url: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests