<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/NCT01688544</url>
  </required_header>
  <id_info>
    <org_study_id>08-112</org_study_id>
    <nct_id>NCT01688544</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic/Pharmacodynamic Study of Ilaprazole to Evaluate the Effect of CYP Genetic Polymorphism</brief_title>
  <official_title>Phase 1 Study to Evaluate the Effect of CYP Polymorphism and Gender on the Pharmacokinetics and Pharmacodynamics of Ilaprazole After Multiple Dosing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inje University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inje University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ilaprazole is a novel proton pump inhibitor and metabolized by CYP3A4 and 2C19. Thus genetic&#xD;
      polymorphisms of CYP3A4 and 2C19 may have effect on the pharmacokinetics and pharmacodynamics&#xD;
      of Ilaprazole.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Effects of genetic polymorphisms on the pharmacokinetics or pharmacodynamics were measured in&#xD;
      healthy Korean volunteers&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2009</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">December 2011</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>24 hour intragastric ph</measure>
    <time_frame>After 7 days dosing of Ilaprazole 10 mg</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameters (Cmax, AUC) of Ilaprazole and its metabolite</measure>
    <time_frame>After 7 days dosing of Ilaprazole</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Gastrin level</measure>
    <time_frame>After 7 days dosing of Ilaprazole</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Ilaprazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Before Ilaprazole dosing, 24 hours intragastric pH monitoring is performed as baseline value.&#xD;
After 7 days dosing of Ilaprazole 10 mg, 24 hours intragastric pH monitoring, serum gastrin level check, and pharmacokinetic sampling is performed</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ilaprazole</intervention_name>
    <description>Ilaprazole 10 mg for 7 days</description>
    <arm_group_label>Ilaprazole</arm_group_label>
    <other_name>2-[(4methoxy-3-methyl)-2-pyridinyl] methylsulfinyl-</other_name>
    <other_name>5-(1H-pyrrol-1yl)-1H-benzimidazole</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy adult volunteer between 20 and 45 years of age and within 20% of ideal body&#xD;
             weight&#xD;
&#xD;
          -  No congenital or acquired chronic disease&#xD;
&#xD;
          -  appropriate for the study judging from examinations (hematology, chemistry, urinalysis&#xD;
             and so on), vital sign and ECG results&#xD;
&#xD;
          -  sign the informed consent form prior to study participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  received any metabolizing enzymes or transporters inducing or inhibiting drugs like&#xD;
             barbiturates within 1 month prior to the date of first drug administration&#xD;
&#xD;
          -  history of hypersensitivity against drugs or clinically significant allergic diseases&#xD;
&#xD;
          -  abnormal laboratory results&#xD;
&#xD;
          -  positive result for helicobacter pylori infection from the Urea Breath Test&#xD;
&#xD;
          -  alcohol or drug abuser&#xD;
&#xD;
          -  pregnant or lactating&#xD;
&#xD;
          -  donated whole blood within 60days prior to the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>JaeGook Shin, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inje University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inje University Busan Paik Hoapital Clinical Trial Center</name>
      <address>
        <city>Busan</city>
        <zip>614-735</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>December 6, 2011</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <last_update_submitted>September 19, 2012</last_update_submitted>
  <last_update_submitted_qc>September 19, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Inje University</investigator_affiliation>
    <investigator_full_name>Jae-Gook Shin</investigator_full_name>
    <investigator_title>Department of Pharmacology and Pharmacogenomics Research Center</investigator_title>
  </responsible_party>
  <keyword>Ilaprazole</keyword>
  <keyword>Intragastric pH</keyword>
  <keyword>Serum Gastrin</keyword>
  <keyword>Pharmacokinetics</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Benzimidazole</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/NCT01688544
org study id: 08-112
nct id: NCT01688544
lead sponsor: 
has dmc: Yes
Ilaprazole is a novel proton pump inhibitor and metabolized by CYP3A4 and 2C19. Thus genetic
      polymorphisms of CYP3A4 and 2C19 may have effect on the pharmacokinetics and pharmacodynamics
      of Ilaprazole.
Effects of genetic polymorphisms on the pharmacokinetics or pharmacodynamics were measured in
      healthy Korean volunteers
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: 24 hour intragastric ph
time frame: After 7 days dosing of Ilaprazole 10 mg
measure: Pharmacokinetic parameters (Cmax, AUC) of Ilaprazole and its metabolite
time frame: After 7 days dosing of Ilaprazole
measure: Serum Gastrin level
time frame: After 7 days dosing of Ilaprazole
arm group label: Ilaprazole
arm group type: Experimental
description: Before Ilaprazole dosing, 24 hours intragastric pH monitoring is performed as baseline value.
After 7 days dosing of Ilaprazole 10 mg, 24 hours intragastric pH monitoring, serum gastrin level check, and pharmacokinetic sampling is performed
intervention type: Drug
intervention name: Ilaprazole
description: Ilaprazole 10 mg for 7 days
arm group label: Ilaprazole
other name: 2-[(4methoxy-3-methyl)-2-pyridinyl] methylsulfinyl-
other name: 5-(1H-pyrrol-1yl)-1H-benzimidazole
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: JaeGook Shin, MD,PhD
role: Principal Investigator
affiliation: Inje University
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Inje University
investigator full name: Jae-Gook Shin
investigator title: Department of Pharmacology and Pharmacogenomics Research Center
mesh term: Benzimidazole