<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/NCT01723891</url>
  </required_header>
  <id_info>
    <org_study_id>HT-002-01</org_study_id>
    <nct_id>NCT01723891</nct_id>
  </id_info>
  <brief_title>Study To Compare Safety and Pharmacokinetic Properties of Surfolase Capsule and HT-002-01 in Healthy Male Volunteers</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hyundai Pharmaceutical Co., LTD.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hyundai Pharmaceutical Co., LTD.</source>
  <brief_summary>
    <textblock>
      Study to compare safety and pharmacokinetic properties of surfolase capsule and HT-002-01&#xD;
      after oral administration for one day in healthy male volunteer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_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, Cmax</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUCinf, Tmax, t1/2</measure>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Surfolase capsule &amp; HT-002-01</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>HT-002-01 &amp; Surfolase capsule</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Surfolase capsule</intervention_name>
    <arm_group_label>HT-002-01 &amp; Surfolase capsule</arm_group_label>
    <arm_group_label>Surfolase capsule &amp; HT-002-01</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HT-002-01</intervention_name>
    <arm_group_label>HT-002-01 &amp; Surfolase capsule</arm_group_label>
    <arm_group_label>Surfolase capsule &amp; HT-002-01</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. healthy male subjects between the age of 20 and 55 years with body mass index between&#xD;
             18.5 and 25&#xD;
&#xD;
          2. Volunteers without apriority of chronic disease&#xD;
&#xD;
          3. Volunteers must be in good health as determined by the investigator based on a&#xD;
             detailed medical history, full physical examination, electrocardiogram, laboratory&#xD;
             tests and urinalysis&#xD;
&#xD;
          4. Volunteers who comply with the protocol, understand and sign an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Sensitive response to acebrophylline and xanthine&#xD;
&#xD;
          2. Galactose intolerance, Lapp lactase deficiency and Glucose-Galactose Malabsorption&#xD;
&#xD;
          3. Known history of renal, hepatic, respiratory, neurologic, endocrine, cardiac vascular&#xD;
             and hematopoietic disease, especially gallstone&#xD;
&#xD;
          4. Known history of gastrointestinal disease which affects the absorption of medicine.&#xD;
&#xD;
          5. Excluded by screening tests&#xD;
&#xD;
          6. Upper limit of AST, ALT&gt;1.25 times Upper limit of total bilirubin&gt;1.5 times&#xD;
&#xD;
          7. Estimated GFR&lt;80mL/min/1.73m2)&#xD;
&#xD;
          8. systolic blood pressure &lt; 90 or &gt; 150, diastolic blood pressure &lt;50 or &gt;100&#xD;
&#xD;
          9. Known history of drug abuse&#xD;
&#xD;
         10. caffeine&gt;5cups/day, alcohol&gt;210g/week, 10 more cigarettes/day&#xD;
&#xD;
         11. Use of any prescription drug within 14days or over-the-counter (OTC) medication within&#xD;
             7 days prior to dosing&#xD;
&#xD;
         12. Participation in any clinical investigation within 60 days prior to study start&#xD;
&#xD;
         13. Donation of blood within 60 days, donation of component blood within 30days&#xD;
&#xD;
         14. Judged by the investigators to be undesirable as subjects&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Yonsei University Health System, Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <last_update_submitted>November 7, 2012</last_update_submitted>
  <last_update_submitted_qc>November 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 8, 2012</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/NCT01723891
org study id: HT-002-01
nct id: NCT01723891
lead sponsor: 
Study to compare safety and pharmacokinetic properties of surfolase capsule and HT-002-01
      after oral administration for one day in healthy male volunteer.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUCt, Cmax
measure: AUCinf, Tmax, t1/2
arm group label: Surfolase capsule & HT-002-01
arm group type: Active Comparator
arm group label: HT-002-01 & Surfolase capsule
arm group type: Active Comparator
intervention type: Drug
intervention name: Surfolase capsule
arm group label: HT-002-01 & Surfolase capsule
arm group label: Surfolase capsule & HT-002-01
intervention type: Drug
intervention name: HT-002-01
arm group label: HT-002-01 & Surfolase capsule
arm group label: Surfolase capsule & HT-002-01
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Sponsor