<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/NCT01663038</url>
  </required_header>
  <id_info>
    <org_study_id>119HPS10F</org_study_id>
    <nct_id>NCT01663038</nct_id>
  </id_info>
  <brief_title>Comparative Pharmacokinetics Study of Clopidogrel and Aspirin Fixed-dose Combination Versus Separate Combination</brief_title>
  <official_title>Comparative Pharmacokinetics of Clopidogrel 75mg and Aspirin 100mg After Single Oral Administration as a Fixed Dose Combination Versus Separate Combination in Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chong Kun Dang Pharmaceutical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Inje University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chong Kun Dang Pharmaceutical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare pharmacokinetics between fixed-dose combination and&#xD;
      separate combination of clopidogrel 75mg/aspirin 100mg.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2010</start_date>
  <completion_date type="Actual">September 2011</completion_date>
  <primary_completion_date type="Actual">January 2011</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>Cmax of clopidogrel/acetylsalicylic acid</measure>
    <time_frame>Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC of clopidogrel/acetylsalicylic acid</measure>
    <time_frame>Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess Cmax of salicylic acid.</measure>
    <time_frame>Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess AUC of salicylic acid.</measure>
    <time_frame>Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Clopidogrel and Aspirin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Copidogrel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clopidogrel</intervention_name>
    <description>Clopidogrel and Aspirin separate combination, single dose</description>
    <arm_group_label>Clopidogrel and Aspirin</arm_group_label>
    <other_name>Clopidogrel: Plavix</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fixed dose combination of clopidogrel/Aspirin</intervention_name>
    <description>Fixed dose combination of clopidogrel/aspirin</description>
    <arm_group_label>Copidogrel</arm_group_label>
    <other_name>Coprigrel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin</intervention_name>
    <arm_group_label>Clopidogrel and Aspirin</arm_group_label>
    <other_name>Aspirin: Astrix</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A healthy male volunteer aged 20 to 55, and within 20% of ideal body weight.&#xD;
&#xD;
          -  Have not any congenital or chronic diseases and medical symptom.&#xD;
&#xD;
          -  Appropriate subject for the study judging from examinations(interview, vital signs,&#xD;
             12-lead ECG, physical examination, blood, urinalysis result on screening.&#xD;
&#xD;
          -  Able to participate in the entire trial.&#xD;
&#xD;
          -  Signed the informed consent form prior to study participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Take metabolic enzyme inducing or inhibiting drugs like barbiturates within 28 days&#xD;
             prior to the first IP administration.&#xD;
&#xD;
          -  show evidence of acute disease within 28 days prior to the first IP administration.&#xD;
&#xD;
          -  Have the medical history of bleeding symptom or bleeding disease&#xD;
&#xD;
          -  Have the disease history(ex. Inflammatory intestinal disease, stomach or duodenum&#xD;
             ulcer, liver and bowels disease, appendectomy except of gastrointestinal surgery&#xD;
             history) that may influence on the absorption, distribution, metabolism and excretion&#xD;
             of the drug.&#xD;
&#xD;
          -  Have relevant hypersensitivity against drug or clinically significant allergic&#xD;
             diseases except mild rhinitis that does not need medication.&#xD;
&#xD;
          -  Have hypersensitivity reaction histories for Clopidogrel or aspirin.&#xD;
&#xD;
          -  Have abnormal laboratory result. AST or ALT &gt; 1.25 times of upper limit/ Total&#xD;
             bilirubin &gt; 1.5 times of upper limit/ PT, aPTT, BT over upper limit/ Platelet count&#xD;
             &lt;150X10^9/L or &gt;350X10^9/L&#xD;
&#xD;
          -  A drug abuse or a heavy caffeine consumer (more than 5cups per a day) or a heavy&#xD;
             smoker (more than 10 cigarettes per a day) or a regular alcohol consumer(more than&#xD;
             30g/day) or drinking within 7days prior to the first IP administration.&#xD;
&#xD;
          -  Have a diet(Especially, grapefruit juice-within 7days prior to the first IP&#xD;
             administration) that may influence on the absorption, distribution, metabolism and&#xD;
             excretion of the drug(s).&#xD;
&#xD;
          -  Have donated whole blood within 60 days prior to the first IP administration.&#xD;
&#xD;
          -  Participated in the other clinical trials within 90days prior to the first IP&#xD;
             administration.&#xD;
&#xD;
          -  Take medicine which affect to this trial within 10 days prior to the first IP&#xD;
             administration.&#xD;
&#xD;
          -  Appropriate subject for the trial judging from principal investigator.&#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>
  <overall_official>
    <last_name>JH Shon, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inje University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inje University Pusan Paik Hospital</name>
      <address>
        <city>Pusan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>December 20, 2010</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>August 10, 2012</last_update_submitted>
  <last_update_submitted_qc>August 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Clopidogrel</keyword>
  <keyword>Aspirin</keyword>
  <keyword>Combination</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Phase 1</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
    <mesh_term>Clopidogrel</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/NCT01663038
org study id: 119HPS10F
nct id: NCT01663038
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to compare pharmacokinetics between fixed-dose combination and
      separate combination of clopidogrel 75mg/aspirin 100mg.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax of clopidogrel/acetylsalicylic acid
time frame: Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h
measure: AUC of clopidogrel/acetylsalicylic acid
time frame: Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h
measure: Assess Cmax of salicylic acid.
time frame: Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h
measure: Assess AUC of salicylic acid.
time frame: Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h
arm group label: Clopidogrel and Aspirin
arm group type: Active Comparator
arm group label: Copidogrel
arm group type: Experimental
intervention type: Drug
intervention name: Clopidogrel
description: Clopidogrel and Aspirin separate combination, single dose
arm group label: Clopidogrel and Aspirin
other name: Clopidogrel: Plavix
intervention type: Drug
intervention name: Fixed dose combination of clopidogrel/Aspirin
description: Fixed dose combination of clopidogrel/aspirin
arm group label: Copidogrel
other name: Coprigrel
intervention type: Drug
intervention name: Aspirin
arm group label: Clopidogrel and Aspirin
other name: Aspirin: Astrix
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: JH Shon, Ph.D
role: Principal Investigator
affiliation: Inje University
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Aspirin
mesh term: Clopidogrel