<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/NCT02988362</url>
  </required_header>
  <id_info>
    <org_study_id>HL068</org_study_id>
    <nct_id>NCT02988362</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study (Candesartan 16 mg and Amlodipine 10 mg)</brief_title>
  <official_title>An Open-label, Randomized, Cross-over Study to Evaluate Pharmacokinetics and the Safety of HL068 16/10mg Compared to Candesartan 16mg and Amlodipine 10mg Co-administered in Healthy Male Volunteers.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HanAll BioPharma Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HanAll BioPharma Co., Ltd.</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the safety and pharmacokinetics of HL068 (Candesartan&#xD;
      16 mg and Amlodipine 10mg) with coadministration of the two separate drugs in healthy male&#xD;
      volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">March 2017</completion_date>
  <primary_completion_date type="Anticipated">February 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>AUCt</measure>
    <time_frame>up to 72 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>up to 72 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUCinf</measure>
    <time_frame>up to 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax</measure>
    <time_frame>up to 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t 1/2β</measure>
    <time_frame>up to 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F</measure>
    <time_frame>up to 72 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Candesartan 16mg and Amlodipine 10mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Candesartan 16mg and Amlodipine 10mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HL068</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HL068(combination of Candesartan 16 mg and Amlodipine 10 mg)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HL068 16/10mg</intervention_name>
    <description>Candesartan 16mg and Amlodipine 10mg</description>
    <arm_group_label>HL068</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Candesartan 16mg and Amlodipine 10mg</intervention_name>
    <arm_group_label>Candesartan 16mg and Amlodipine 10mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male volunteer in the age between 19 and 55 years old.&#xD;
&#xD;
          -  Body mass index (BMI) in the range of 18.5 to 27.0 kg/m2&#xD;
&#xD;
          -  Understand the requirements of the study and voluntarily consent to participate in the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous history or present of clinically significant digestive , cardiovascular,&#xD;
             respiratory, psychiatric, endocrine, hepatobiliary, renal disease.&#xD;
&#xD;
          -  History of gastrointestinal disease or gastrointestinal surgery to affect drug&#xD;
             absorption.&#xD;
&#xD;
          -  Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase&#xD;
             deficiency or glucose-galactose malabsorption.&#xD;
&#xD;
          -  Subjects whose clinical laboratory test values are outside the accepted normal range.&#xD;
             Especially, ASTor ALT &gt;1.5 times of the Upper Normal Limit or total bilirubin &gt; 1.5&#xD;
             times of the Upper Normal Limit&#xD;
&#xD;
          -  Positive test results for Hepatitis B antibodies, Hepatitis C virus antibody, and&#xD;
             Syphilis regain test&#xD;
&#xD;
          -  Participation in any clinical investigation within 3 months prior to study drug&#xD;
             administration&#xD;
&#xD;
          -  Subjects with whole blood donation within 60 days or component blood donation within&#xD;
             30days or blood transfusion within 30days prior to the first dosing.&#xD;
&#xD;
          -  SBP ≥ 140 mmHg or&lt; 115 mmHg, DBP ≥ 90 mmHg or &lt; 70 mmHg&#xD;
&#xD;
          -  Caffeine &gt; 400mg/day&#xD;
&#xD;
          -  Alcohol &gt; 30g/day&#xD;
&#xD;
          -  Cigarette &gt; 10 cigarettes/day.&#xD;
&#xD;
          -  Subjects who are judged unsuitable by investigators&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Young-Ran Yoon, M.D, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>KYUNGPOOK NATIONAL UNIVERSITY HOSPITAL CLINICAL TRIAL CENTER</affiliation>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>December 8, 2016</last_update_submitted>
  <last_update_submitted_qc>December 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2016</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>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amlodipine</mesh_term>
    <mesh_term>Candesartan</mesh_term>
    <mesh_term>Candesartan cilexetil</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/NCT02988362
org study id: HL068
nct id: NCT02988362
lead sponsor: 
The purpose of this study is to compare the safety and pharmacokinetics of HL068 (Candesartan
      16 mg and Amlodipine 10mg) with coadministration of the two separate drugs in healthy male
      volunteers.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUCt
time frame: up to 72 hours
measure: Cmax
time frame: up to 72 hours
measure: AUCinf
time frame: up to 72 hours
measure: Tmax
time frame: up to 72 hours
measure: t 1/2β
time frame: up to 72 hours
measure: CL/F
time frame: up to 72 hours
arm group label: Candesartan 16mg and Amlodipine 10mg
arm group type: Experimental
description: Candesartan 16mg and Amlodipine 10mg
arm group label: HL068
arm group type: Experimental
description: HL068(combination of Candesartan 16 mg and Amlodipine 10 mg)
intervention type: Drug
intervention name: HL068 16/10mg
description: Candesartan 16mg and Amlodipine 10mg
arm group label: HL068
intervention type: Drug
intervention name: Candesartan 16mg and Amlodipine 10mg
arm group label: Candesartan 16mg and Amlodipine 10mg
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Young-Ran Yoon, M.D, Ph.D
role: Principal Investigator
affiliation: KYUNGPOOK NATIONAL UNIVERSITY HOSPITAL CLINICAL TRIAL CENTER
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Amlodipine
mesh term: Candesartan
mesh term: Candesartan cilexetil