<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/NCT02233972</url>
  </required_header>
  <id_info>
    <org_study_id>Z-YXPU-ZS-IV5</org_study_id>
    <nct_id>NCT02233972</nct_id>
  </id_info>
  <brief_title>A Drug-Drug Interaction Study To Investigate The Ginkgolides Meglumine Injection To Alter The Pharmacokinetics Of Midazolam</brief_title>
  <official_title>A Drug-Drug Interaction Study To Investigate The Ginkgolides Meglumine Injection To Alter The Pharmacokinetics Of Midazolam.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu Kanion Pharmaceutical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu Kanion Pharmaceutical Co., Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open label, randomized, Parallel Assignment, placebo-controlled study. One of the&#xD;
      purposes of this study is to investigate the multiple dosing Ginkgolides Meglumine Injection&#xD;
      to alter the pharmacokinetics of Midazolam, the other is to calculate the pharmacokinetic&#xD;
      parameters after Single and multiple dosing of Ginkgolides Meglumine Injection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics parameters：Cmax、Tmax、AUC0-24h、T1/2、CL/F、Vz/F for Midazolam.</measure>
    <time_frame>Day 1 and Day 22</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics parameters：AUC0-24h（Day 22/ Day 1）、Cmax（Day 22/ Day 1）for Midazolam.</measure>
    <time_frame>Day 1 and Day 22</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics parameters：Cmax、Tmax、AUC0-24h、T1/2、CL/F、Vz/F for Ginkgolides Meglumine Injection.</measure>
    <time_frame>Day 8</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics parameters：T1/2、CL/F、Vz/F、Cmax,ss、Cmin,ss、Cav,ss、Tmax,ss、AUCtau,ss for Ginkgolides Meglumine Injection.</measure>
    <time_frame>Day 19 and Day22</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics parameters: Racc for Ginkgolides Meglumine Injection.</measure>
    <time_frame>Day 19</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, electrocardiograph monitoring and clinical laboratory tests.</measure>
    <time_frame>Day 0, Day 1, Day 8-22 and Day 23</time_frame>
    <description>Adverse event reports will be assessed at Day1, Day 8-22, Day 23. Vital sign measurements will be assessed at Screening stage, Day 0, Day 1, Day 8-22, Day 23. Electrocardiogram monitoring will be assessed at Day 1, Day 8-22. Clinical laboratory tests will be assessed at Screening stage and Day 23. Electrocardiogram will be assessed at Screening stage, Day 0, Day 8-22 and Day 23</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Pharmacokinetics</condition>
  <arm_group>
    <arm_group_label>Midazolam and Ginkgolides Meglumine Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Midazolam: tablet, 7.5 mg. Midazolam will be taken on Day 1 and Day 22. Ginkgolides Meglumine Injection: 25mg, intravenous drip, once a day. It will be used on Day 8 -Day 21, 14 days totally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Midazolam and placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Midazolam: tablet, 7.5 mg. Midazolam will be taken on Day 1 and Day 22. Placebo: Sodium Chloride Injection, 250 ml, intravenous drip, once a day. It will be used on Day 8 -Day 21, 14 days totally.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam</intervention_name>
    <arm_group_label>Midazolam and Ginkgolides Meglumine Injection</arm_group_label>
    <arm_group_label>Midazolam and placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ginkgolides Meglumine Injection</intervention_name>
    <arm_group_label>Midazolam and Ginkgolides Meglumine Injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>Midazolam and placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 18-40.&#xD;
&#xD;
          -  Male.&#xD;
&#xD;
          -  Subjects have standard weight( generally not less than 50 kg), and body mass index&#xD;
             (BMI) within 19-25.&#xD;
&#xD;
          -  All physical examinations( including ECG, kidney function, liver function, blood&#xD;
             routine, urine routines, etc) are normal.&#xD;
&#xD;
          -  Subjects have no history of significant diseases, allergy or orthostatic hypotension.&#xD;
&#xD;
          -  All subjects sign the informed consent after being informed all possible adverse drug&#xD;
             reaction and .are able to complete all examination defined.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who cannot communicate with medical staff, and subjects with cerebral&#xD;
             insufficiency or psychological problem.&#xD;
&#xD;
          -  Partner of subjects have plan to pregnant.&#xD;
&#xD;
          -  Subject have primary disease in vital organ.&#xD;
&#xD;
          -  Subjects have a history of drug dependence or psychosis in last 2 years.&#xD;
&#xD;
          -  Subjects with severe blood loss or blood donation more than 200 mL in the prior 3&#xD;
             months.&#xD;
&#xD;
          -  Subjects who have participated in another clinical trial within the prior 3 months.&#xD;
&#xD;
          -  Known or suspected to have a history of alcohol or drug abuse.&#xD;
&#xD;
          -  Subjects who have abnormal clinical significance after checking preclinical laboratory&#xD;
             data and physical examinations.&#xD;
&#xD;
          -  Known allergy to pharmaceutical ingredient of Ginkgolides Meglumine Injection or&#xD;
             allergy sufferers who are allergic to more than two kinds of food or drugs in the&#xD;
             past.&#xD;
&#xD;
          -  Subjects who have used any drugs in the prior 2 weeks.&#xD;
&#xD;
          -  Subjects have unexplained infections.&#xD;
&#xD;
          -  The subjects could not complete the study in the opinion of the Principal Investigator&#xD;
             due to any reason.&#xD;
&#xD;
          -  Subjects who test positive at screening for human immunodeficiency virus (HIV),&#xD;
             hepatitis C virus (HCV) , hepatitis B surface antigen (HbsAg), etc.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ou Ning</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>October 16, 2014</last_update_submitted>
  <last_update_submitted_qc>October 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Ginkgolides Meglumine Injection</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Midazolam</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/NCT02233972
org study id: Z-YXPU-ZS-IV5
nct id: NCT02233972
lead sponsor: 
has dmc: No
This is an open label, randomized, Parallel Assignment, placebo-controlled study. One of the
      purposes of this study is to investigate the multiple dosing Ginkgolides Meglumine Injection
      to alter the pharmacokinetics of Midazolam, the other is to calculate the pharmacokinetic
      parameters after Single and multiple dosing of Ginkgolides Meglumine Injection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Pharmacokinetics parameters：Cmax、Tmax、AUC0-24h、T1/2、CL/F、Vz/F for Midazolam.
time frame: Day 1 and Day 22
measure: Pharmacokinetics parameters：AUC0-24h（Day 22/ Day 1）、Cmax（Day 22/ Day 1）for Midazolam.
time frame: Day 1 and Day 22
measure: Pharmacokinetics parameters：Cmax、Tmax、AUC0-24h、T1/2、CL/F、Vz/F for Ginkgolides Meglumine Injection.
time frame: Day 8
measure: Pharmacokinetics parameters：T1/2、CL/F、Vz/F、Cmax,ss、Cmin,ss、Cav,ss、Tmax,ss、AUCtau,ss for Ginkgolides Meglumine Injection.
time frame: Day 19 and Day22
measure: Pharmacokinetics parameters: Racc for Ginkgolides Meglumine Injection.
time frame: Day 19
measure: Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, electrocardiograph monitoring and clinical laboratory tests.
time frame: Day 0, Day 1, Day 8-22 and Day 23
description: Adverse event reports will be assessed at Day1, Day 8-22, Day 23. Vital sign measurements will be assessed at Screening stage, Day 0, Day 1, Day 8-22, Day 23. Electrocardiogram monitoring will be assessed at Day 1, Day 8-22. Clinical laboratory tests will be assessed at Screening stage and Day 23. Electrocardiogram will be assessed at Screening stage, Day 0, Day 8-22 and Day 23
arm group label: Midazolam and Ginkgolides Meglumine Injection
arm group type: Experimental
description: Midazolam: tablet, 7.5 mg. Midazolam will be taken on Day 1 and Day 22. Ginkgolides Meglumine Injection: 25mg, intravenous drip, once a day. It will be used on Day 8 -Day 21, 14 days totally.
arm group label: Midazolam and placebo
arm group type: Placebo Comparator
description: Midazolam: tablet, 7.5 mg. Midazolam will be taken on Day 1 and Day 22. Placebo: Sodium Chloride Injection, 250 ml, intravenous drip, once a day. It will be used on Day 8 -Day 21, 14 days totally.
intervention type: Drug
intervention name: Midazolam
arm group label: Midazolam and Ginkgolides Meglumine Injection
arm group label: Midazolam and placebo
intervention type: Drug
intervention name: Ginkgolides Meglumine Injection
arm group label: Midazolam and Ginkgolides Meglumine Injection
intervention type: Drug
intervention name: placebo
arm group label: Midazolam and placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ou Ning
role: Principal Investigator
affiliation: First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
facility: 
country: China
responsible party type: Sponsor
mesh term: Midazolam