<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/NCT03794843</url>
  </required_header>
  <id_info>
    <org_study_id>BJK-PK-NMDP-201801</org_study_id>
    <nct_id>NCT03794843</nct_id>
  </id_info>
  <brief_title>Bioavailability Comparison Study of Two Types of Nimodipine Injections in Healthy Volunteers</brief_title>
  <official_title>A Randomized, Open-label, Single Dose, Two Formulation, Two Period, Double Cross Over Bioavailability Comparison Study of Two Types of Nimodipine Injections in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shenyang Dongxing Pharmaceutical Technology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Xuanwu Hospital, Beijing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shenyang Dongxing Pharmaceutical Technology Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Randomized, Open-label, Single Dose, Two Formulation, Two Period, Double Cross Over&#xD;
      Bioavailability Comparison Study of two types of Nimodipine Injections in Healthy Volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigation product Nimodipine Injection (II) was supplied by Shenyang Dongxing&#xD;
      Pharmaceutical Technology Co., Ltd.And Nimodipine injection (trade name: Nimotop)&#xD;
      manufactured by Bayer Pharma AG was used as the reference preparation.The volunteers were&#xD;
      administered with Nimodipine injection for intravenous infusion (containing nimodipine 11 mg)&#xD;
      for 12 consecutive hours, respectively.The Venous blood was collected at 0 hours before the&#xD;
      administration (ie, 1 hour before the administration) and 10 minutes, 20 minutes, 30 minutes,&#xD;
      45 minutes, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h (Administration was over) and 12.5 h, 13&#xD;
      h, 14 h, 16 h, 19 h, 22 h, 25 h, 36 h, 3 ml per blood collection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 23, 2018</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2019</primary_completion_date>
  <phase>Early 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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC</measure>
    <time_frame>Within 36 hours after starting the administration</time_frame>
    <description>Evaluation of bioequivalence based on pharmacokinetic parameters such as AUC</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>Within 36 hours after starting the administration</time_frame>
    <description>Evaluation of bioequivalence based on pharmacokinetic parameters such as Cmax</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">26</enrollment>
  <condition>Bioavailability</condition>
  <condition>Safety Issues</condition>
  <condition>Ischemic Cerebrovascular Disease</condition>
  <arm_group>
    <arm_group_label>Nimodipine Injection (II)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The specification of this injection is 5 ml: 4 mg , which is administered by constant infusion intravenously with an infusion pump. The injection and 0.9% sodium chloride injection is simultaneously infused at a ratio of 1:16 (injection: combined infusion). The rate of intravenous drip was started at 0.5 mg/h for 2 hours, and the rate of intravenous drip was 1.0 mg/h after 2 hours, and continuous infusion for 12 hours, for a total of 11 mg of nimodipine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nimodipine Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The specification of this injection is 50 ml: 10 mg ,which is administered by constant infusion intravenously with an infusion pump. The injection and 0.9% sodium chloride injection is simultaneously infused at a ratio of 1:4 (injection: combined infusion). The rate of intravenous drip was started at 0.5 mg/h for 2 hours, and the rate of intravenous drip was 1.0 mg/h after 2 hours, and continuous infusion for 12 hours, for a total of 11 mg of nimodipine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nimodipine Injection</intervention_name>
    <description>Nimodipine injection (trade name: Nimotop) manufactured by Bayer Pharma AG was used as the reference preparation</description>
    <arm_group_label>Nimodipine Injection</arm_group_label>
    <other_name>Nimotop</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nimodipine Injection (II)</intervention_name>
    <description>Nimodipine Injection (II) was supplied by Shenyang Dongxing Pharmaceutical Technology Co., Ltd</description>
    <arm_group_label>Nimodipine Injection (II)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Sign the informed consent form before the study, and fully understand the test&#xD;
             content, process and possible adverse reactions, and be able to comply with the&#xD;
             protocol according to the test plan requirements;&#xD;
&#xD;
          2. Healthy subjects, both male and female;&#xD;
&#xD;
          3. Age ≥ 18 years old;&#xD;
&#xD;
          4. Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index in the range of 19 ~ 26&#xD;
             (including the critical value)[Body mass index (BMI) = weight (kg) / height 2 (m2)].&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Subject who is in one of the following conditions may not be eligible.&#xD;
&#xD;
          1. Those who smoke more than 5 cigarettes per day for 3 months before the test or who&#xD;
             cannot stop smoking during the trial period;&#xD;
&#xD;
          2. Allergies, such as those who are allergic to drugs, food and pollen, or those known to&#xD;
             be allergic to nimodipine;&#xD;
&#xD;
          3. Those who have a history of alcohol abuse 6 months before the test (defined as&#xD;
             drinking 14 units of alcohol per week: 1 unit = 285 ml of beer, or high-alcohol (50%&#xD;
             or more alcohol) 25 ml, or 150 ml of wine) or Drinkers cannot be stopped during the&#xD;
             trial;&#xD;
&#xD;
          4. Donor blood or a large amount of blood loss ≥400 ml (excluding female menstrual blood&#xD;
             volume) within 3 months before the test, or have a history of halo and fainting;&#xD;
&#xD;
          5. Anyone taking any drug within 14 days before the test;&#xD;
&#xD;
          6. Antidepressants (such as fluoxetine), nortriptyline, norfloxacin, anti-HIV drugs (such&#xD;
             as azidothymidine), calcium antagonists (such as nifedipine), were used within 28 days&#xD;
             prior to the test. Diltiazem, verapamil, alpha-methyldopa and other antihypertensive&#xD;
             drugs;&#xD;
&#xD;
          7. Have taken the study drug within 3 months before the test, or participated in any drug&#xD;
             or medical device clinical trial;&#xD;
&#xD;
          8. Clinical laboratory examination, vital signs, physical examination, and 12-lead ECG&#xD;
             abnormalities in the screening period are clinically significant;&#xD;
&#xD;
          9. During screening, when staying in the clinical center, the supine pressure of the&#xD;
             supine position is not in the range of 100~139 mmHg, and the diastolic pressure in the&#xD;
             supine position is not in the range of 60~89 mmHg;&#xD;
&#xD;
         10. During screening, when staying in the clinical center, the pulse is not in the range&#xD;
             of 60~100 beats/min before each dose;&#xD;
&#xD;
         11. There is a serious arrhythmia: QTc interval prolongation (QTc over 450 ms), or QTc&#xD;
             interval prolongation syndrome or family history of sudden death&#xD;
&#xD;
         12. A positive result of screening for hepatitis B surface antigen, hepatitis C virus&#xD;
             antibody, human immunodeficiency virus antibody or Treponema pallidum-specific&#xD;
             antibody;&#xD;
&#xD;
         13. Health status: a history of major diseases or important organ diseases such as nervous&#xD;
             system, mental system, respiratory system, cardiovascular system, digestive system,&#xD;
             blood system, endocrine system, musculoskeletal or metabolic abnormalities;&#xD;
&#xD;
         14. pregnant and lactating women;&#xD;
&#xD;
         15. Female subjects of childbearing age have a pregnancy plan or unable to take effective&#xD;
             contraception after the first dose and within 3 months after the last dose, from 30&#xD;
             days before screening to 3 months after the last dose. Measures (non-pharmaceutical&#xD;
             contraception), see the appendix for specific contraceptive measures;&#xD;
&#xD;
         16. Can not stop taking chocolate, any caffeinated food or drink during the test; or eat&#xD;
             any food or drink containing grapefruit ingredients 14 days before the first dose to&#xD;
             the end of the test;&#xD;
&#xD;
         17. Those who are positive for alcohol screening before dosing, or who have taken any&#xD;
             alcoholic products within 24 hours prior to dosing;&#xD;
&#xD;
         18. Those who are positive for drug screening, who have had a history of drug abuse in the&#xD;
             past five years or who have used drugs three months before the trial;&#xD;
&#xD;
         19. Investigators believe that it is not appropriate to participate in this test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Zhang Lan, Doctor</last_name>
    <phone>+86-010-83198855</phone>
    <email>xwphase1@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Xuanwu Hospital Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ZHANG LAN, doctor</last_name>
      <phone>010-83198855</phone>
      <email>xwphase1@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>January 6, 2019</last_update_submitted>
  <last_update_submitted_qc>January 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nimodipine</keyword>
  <keyword>bioavailability</keyword>
  <keyword>Safety</keyword>
  <keyword>ischemic cerebrovascular disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebrovascular Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nimodipine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03794843
org study id: BJK-PK-NMDP-201801
nct id: NCT03794843
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A Randomized, Open-label, Single Dose, Two Formulation, Two Period, Double Cross Over
      Bioavailability Comparison Study of two types of Nimodipine Injections in Healthy Volunteers.
The investigation product Nimodipine Injection (II) was supplied by Shenyang Dongxing
      Pharmaceutical Technology Co., Ltd.And Nimodipine injection (trade name: Nimotop)
      manufactured by Bayer Pharma AG was used as the reference preparation.The volunteers were
      administered with Nimodipine injection for intravenous infusion (containing nimodipine 11 mg)
      for 12 consecutive hours, respectively.The Venous blood was collected at 0 hours before the
      administration (ie, 1 hour before the administration) and 10 minutes, 20 minutes, 30 minutes,
      45 minutes, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h (Administration was over) and 12.5 h, 13
      h, 14 h, 16 h, 19 h, 22 h, 25 h, 36 h, 3 ml per blood collection.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: AUC
time frame: Within 36 hours after starting the administration
description: Evaluation of bioequivalence based on pharmacokinetic parameters such as AUC
measure: Cmax
time frame: Within 36 hours after starting the administration
description: Evaluation of bioequivalence based on pharmacokinetic parameters such as Cmax
arm group label: Nimodipine Injection (II)
arm group type: Experimental
description: The specification of this injection is 5 ml: 4 mg , which is administered by constant infusion intravenously with an infusion pump. The injection and 0.9% sodium chloride injection is simultaneously infused at a ratio of 1:16 (injection: combined infusion). The rate of intravenous drip was started at 0.5 mg/h for 2 hours, and the rate of intravenous drip was 1.0 mg/h after 2 hours, and continuous infusion for 12 hours, for a total of 11 mg of nimodipine.
arm group label: Nimodipine Injection
arm group type: Experimental
description: The specification of this injection is 50 ml: 10 mg ,which is administered by constant infusion intravenously with an infusion pump. The injection and 0.9% sodium chloride injection is simultaneously infused at a ratio of 1:4 (injection: combined infusion). The rate of intravenous drip was started at 0.5 mg/h for 2 hours, and the rate of intravenous drip was 1.0 mg/h after 2 hours, and continuous infusion for 12 hours, for a total of 11 mg of nimodipine.
intervention type: Drug
intervention name: Nimodipine Injection
description: Nimodipine injection (trade name: Nimotop) manufactured by Bayer Pharma AG was used as the reference preparation
arm group label: Nimodipine Injection
other name: Nimotop
intervention type: Drug
intervention name: Nimodipine Injection (II)
description: Nimodipine Injection (II) was supplied by Shenyang Dongxing Pharmaceutical Technology Co., Ltd
arm group label: Nimodipine Injection (II)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Zhang Lan, Doctor
phone: +86-010-83198855
email: xwphase1@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Cerebrovascular Disorders
mesh term: Nimodipine
sharing ipd: No