<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/NCT01692717</url>
  </required_header>
  <id_info>
    <org_study_id>ALHHYP0512OR-I</org_study_id>
    <secondary_id>Version 01 May 28, 2012</secondary_id>
    <nct_id>NCT01692717</nct_id>
  </id_info>
  <brief_title>Clinical Assessment Of Association Pharmacokinetics Atorvastatin + Losartana + Hydrochlorothiazide</brief_title>
  <official_title>Clinical Assessment Of Association Pharmacokinetics Atorvastatin + Losartana + Hydrochlorothiazide Produced By Lab Hypermarcas S/A In Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azidus Brasil</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azidus Brasil</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>
      The objective of this clinical study, randomized, crossover is to evaluate the&#xD;
      pharmacokinetic profile of the polypill (atorvastatin + lorsatana + hydrochlorothiazide)&#xD;
      Laboratory Hypermarcas S / A, in relation to drugs Citalor ® (atovastatina - Pfizer) and&#xD;
      Hyzaar ® (losartan + hydrochlorothiazide - Merck Sharp &amp; Dohme) by comparing the serum&#xD;
      concentration of analytes unchanged (AT, LS and HCTZ) in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The pharmacokinetic profile of the drug will also be assessed by comparing the serum&#xD;
      concentration of active metabolites following:&#xD;
&#xD;
        -  O-hydroxy atorvastatin (2-Hydroxy atorvastatin, O-HAT): metabolite of AT&#xD;
&#xD;
        -  carboxylic acid (E-3174, LS-CA): active metabolite of LS&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 28, 2013</start_date>
  <completion_date type="Actual">May 31, 2013</completion_date>
  <primary_completion_date type="Actual">May 31, 2013</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>The primary pharmacokinetic parameters for the exercise of comparability will be unchanged dosages of analytes (AT, LS and HCTZ), assessed by AUC, Tmax, Cmax and T1 / 2.</measure>
    <time_frame>0h00, 0h15, 0h30, 0h45, 1h00, 1h15, 1h30, 1h45, 2h00, 2h30, 3h00, 3h30, 4h00, 4h30, 5h00, 6h00, 8h00, 10h00, 12h00, 18h00, 24h00, 36h00, 48h00, 56h00 e 72h00.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameters are side dosages of active metabolites O-HAT and E-3174, measured by AUC, Tmax, Cmax and T1 / 2.</measure>
    <time_frame>0h00, 0h15, 0h30, 0h45, 1h00, 1h15, 1h30, 1h45, 2h00, 2h30, 3h00, 3h30, 4h00, 4h30, 5h00, 6h00, 8h00, 10h00, 12h00, 18h00, 24h00, 36h00, 48h00, 56h00 e 72h00.</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>Atorvastatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Citalor (Atorvastatin) - Pfizer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hydrochlorothiazide + Losartan</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hyzaar (Hydrochlorothiazide + Losartan) - Merck Sharp &amp; Dohme</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atorvastatin + Hydrochlorothiazide + Losartan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Polipílula (Atorvastatin + Hydrochlorothiazide + Losartan) - Lab Hypermarcas</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin</intervention_name>
    <description>10 mg</description>
    <arm_group_label>Atorvastatin</arm_group_label>
    <arm_group_label>Atorvastatin + Hydrochlorothiazide + Losartan</arm_group_label>
    <arm_group_label>Hydrochlorothiazide + Losartan</arm_group_label>
    <other_name>Citalor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydrochlorothiazide + Losartan</intervention_name>
    <description>12.5 mg + 50 mg</description>
    <arm_group_label>Atorvastatin</arm_group_label>
    <arm_group_label>Atorvastatin + Hydrochlorothiazide + Losartan</arm_group_label>
    <arm_group_label>Hydrochlorothiazide + Losartan</arm_group_label>
    <other_name>Hyzaar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydrochlorothiazide + Losartan + Atorvastatin</intervention_name>
    <description>12.5 mg + 50 mg + 10 mg</description>
    <arm_group_label>Atorvastatin</arm_group_label>
    <arm_group_label>Atorvastatin + Hydrochlorothiazide + Losartan</arm_group_label>
    <arm_group_label>Hydrochlorothiazide + Losartan</arm_group_label>
    <other_name>Polipílula</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Confirm voluntary participation and agree to all the purposes of the study by signing&#xD;
             and dating the IC in two ways;&#xD;
&#xD;
          2. Age between 18 and 55 years, regardless of sex, clinically healthy and present&#xD;
             laboratory parameters within normal limits;&#xD;
&#xD;
          3. BMI ≥ 18.5 and ≤ 30.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participation in clinical trials in the 12 months preceding the survey;&#xD;
&#xD;
          2. History of hypersensitivity reactions to atorvastatin, losartan hydrochlorothiazide&#xD;
             and / or any other ingredients of medicines;&#xD;
&#xD;
          3. Alterations in clinical and laboratory criteria that interfere Principal Investigator&#xD;
             on the study results;&#xD;
&#xD;
          4. Presence of pulmonary diseases, cardiovascular, neurological, endocrine,&#xD;
             gastrointestinal, genitourinary or other systems;&#xD;
&#xD;
          5. Acute illness during the 07 days preceding the start of the study;&#xD;
&#xD;
          6. Chronic disease that determine drug delivery, such as hypertension, diabetes or any&#xD;
             other that requires continuous use of any medicine, including use of vitamins, mineral&#xD;
             supplements and OTCs (over-the-counter);&#xD;
&#xD;
          7. Having made regular use of medication in the last 02 weeks before the onset of the&#xD;
             study. The use of any medication that does not interfere with the physician's judgment&#xD;
             on the pharmacokinetics of the drug under study, will not be considered as an&#xD;
             exclusion criterion.&#xD;
&#xD;
          8. Use of medications that interact with any medications association;&#xD;
&#xD;
          9. History of or current use for at least 12 months of tobacco;&#xD;
&#xD;
         10. Current or previous history (under 12 months) of illicit drug use;&#xD;
&#xD;
         11. At the discretion of the Principal Investigator of the study.&#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>LAL Clínica Pesquisa e Desenvolvimento Ltda</name>
      <address>
        <city>Valinhos</city>
        <state>São Paulo</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>October 27, 2022</last_update_submitted>
  <last_update_submitted_qc>October 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 2022</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>Losartan</mesh_term>
    <mesh_term>Hydrochlorothiazide</mesh_term>
    <mesh_term>Atorvastatin</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/NCT01692717
org study id: ALHHYP0512OR-I
secondary id: Version 01 May 28, 2012
nct id: NCT01692717
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of this clinical study, randomized, crossover is to evaluate the
      pharmacokinetic profile of the polypill (atorvastatin + lorsatana + hydrochlorothiazide)
      Laboratory Hypermarcas S / A, in relation to drugs Citalor ® (atovastatina - Pfizer) and
      Hyzaar ® (losartan + hydrochlorothiazide - Merck Sharp & Dohme) by comparing the serum
      concentration of analytes unchanged (AT, LS and HCTZ) in healthy subjects.
The pharmacokinetic profile of the drug will also be assessed by comparing the serum
      concentration of active metabolites following:

        -  O-hydroxy atorvastatin (2-Hydroxy atorvastatin, O-HAT): metabolite of AT

        -  carboxylic acid (E-3174, LS-CA): active metabolite of LS
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The primary pharmacokinetic parameters for the exercise of comparability will be unchanged dosages of analytes (AT, LS and HCTZ), assessed by AUC, Tmax, Cmax and T1 / 2.
time frame: 0h00, 0h15, 0h30, 0h45, 1h00, 1h15, 1h30, 1h45, 2h00, 2h30, 3h00, 3h30, 4h00, 4h30, 5h00, 6h00, 8h00, 10h00, 12h00, 18h00, 24h00, 36h00, 48h00, 56h00 e 72h00.
measure: Pharmacokinetic parameters are side dosages of active metabolites O-HAT and E-3174, measured by AUC, Tmax, Cmax and T1 / 2.
time frame: 0h00, 0h15, 0h30, 0h45, 1h00, 1h15, 1h30, 1h45, 2h00, 2h30, 3h00, 3h30, 4h00, 4h30, 5h00, 6h00, 8h00, 10h00, 12h00, 18h00, 24h00, 36h00, 48h00, 56h00 e 72h00.
arm group label: Atorvastatin
arm group type: Active Comparator
description: Citalor (Atorvastatin) - Pfizer
arm group label: Hydrochlorothiazide + Losartan
arm group type: Active Comparator
description: Hyzaar (Hydrochlorothiazide + Losartan) - Merck Sharp & Dohme
arm group label: Atorvastatin + Hydrochlorothiazide + Losartan
arm group type: Experimental
description: Polipílula (Atorvastatin + Hydrochlorothiazide + Losartan) - Lab Hypermarcas
intervention type: Drug
intervention name: Atorvastatin
description: 10 mg
arm group label: Atorvastatin
arm group label: Atorvastatin + Hydrochlorothiazide + Losartan
arm group label: Hydrochlorothiazide + Losartan
other name: Citalor
intervention type: Drug
intervention name: Hydrochlorothiazide + Losartan
description: 12.5 mg + 50 mg
arm group label: Atorvastatin
arm group label: Atorvastatin + Hydrochlorothiazide + Losartan
arm group label: Hydrochlorothiazide + Losartan
other name: Hyzaar
intervention type: Drug
intervention name: Hydrochlorothiazide + Losartan + Atorvastatin
description: 12.5 mg + 50 mg + 10 mg
arm group label: Atorvastatin
arm group label: Atorvastatin + Hydrochlorothiazide + Losartan
arm group label: Hydrochlorothiazide + Losartan
other name: Polipílula
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Losartan
mesh term: Hydrochlorothiazide
mesh term: Atorvastatin