<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/NCT04466748</url>
  </required_header>
  <id_info>
    <org_study_id>3571-CPK-1003</org_study_id>
    <nct_id>NCT04466748</nct_id>
  </id_info>
  <brief_title>A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects</brief_title>
  <official_title>A Single-center, Randomized, Double-blinded, Placebo Parallel Controlled Phase 1 Study to Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of Multiple Ascending Dose Administration of Anaprazole in Healthy Chinese Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sihuan Pharmaceutical Holdings Group Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sihuan Pharmaceutical Holdings Group Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A single-center, randomized, double-blinded, placebo parallel controlled phase 1 study to&#xD;
      evaluate the safety and pharmacokinetics/pharmacodynamics of multiple (6 days) ascending dose&#xD;
      (20mg QD, 40mg QD, 20mg Bid) administrationof Anaprazole in healthy Chinese subjects. 36&#xD;
      subjects, 12 subjects for each dose group. In each dose group, 10 subjects take anaprazole, 2&#xD;
      subjects take placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 8, 2015</start_date>
  <completion_date type="Actual">December 29, 2015</completion_date>
  <primary_completion_date type="Actual">December 29, 2015</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects with adverse events and serious adverse events as assessed by CTCAE v5.0</measure>
    <time_frame>From signing informed consent to study completion, 15 days after fist dose administration</time_frame>
    <description>All adverse events will be monitored in each subject</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC of anaprazole (parent drug, KBP-3571) and its enantiomer（KBP-3570）and its major metabolites</measure>
    <time_frame>10 minutes pre-dose and 1.5、2、2.5、3、3.5、4、4.5、5、6、7、8、10、12、15、24 hours post-dose of Day 0 and Day 6</time_frame>
    <description>AUC is area under the plasma concentration-time curve</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax of anaprazole (parent drug, KBP-3571) and its enantiomer（KBP-3570）and its major metabolites</measure>
    <time_frame>10 minutes pre-dose and 1.5、2、2.5、3、3.5、4、4.5、5、6、7、8、10、12、15、24 hours post-dose of Day 0 and Day 6</time_frame>
    <description>Cmax is the peak plasma concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax of anaprazole (parent drug, KBP-3571) and its enantiomer（KBP-3570）and its major metabolites</measure>
    <time_frame>10 minutes pre-dose and 1.5、2、2.5、3、3.5、4、4.5、5、6、7、8、10、12、15、24 hours post-dose of Day 0 and Day 6</time_frame>
    <description>Tmax is the time to peak plasma concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time percentage of gastric pH value&gt;3 in 24 hours gastric pH monitoring post dose at day 6</measure>
    <time_frame>24 hours post-dose at day 6</time_frame>
    <description>Time percentage gastric pH value&gt;3 is duration (hours) of gastric pH value&gt;3 divided to 24 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time percentage of gastric pH value&gt;4 in 24 hours gastric pH monitoring post dose at day 6</measure>
    <time_frame>24 hours post-dose at day 6</time_frame>
    <description>Time percentage gastric pH value&gt;4 is duration (hours) of gastric pH value&gt;3 divided to 24 hours</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Anaprazole Sodium enteric-coated tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>&quot;Multiple ascendinng dose, anaprazole 20mg QD(20mg QD group), 40mg QD(40mg QD group), 20mg Bid(20mg Bid group) , 6 days, fasting oral administration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Multiple dose, 1 tablet QD (20mg QD and 40mg QD group), 1 tablet Bid (20mg Bid group), 6 days, fasting oral administration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anaprazole Sodium enteric-coated tablet</intervention_name>
    <description>Multiple ascendinng dose, anaprazole 20mg QD(20mg QD group), 40mg QD(40mg QD group), 20mg Bid(20mg Bid group) , 6 days, fasting oral administration.</description>
    <arm_group_label>Anaprazole Sodium enteric-coated tablet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Multiple dose, 1 tablet QD (20mg QD and 40mg QD group), 1 tablet Bid (20mg Bid group), 6 days, fasting oral administration.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subject is capable of understanding and complying with protocol requirements, and&#xD;
             signed and dated a written informed consent form voluntarily;&#xD;
&#xD;
          2. The subject is a Chinese health adult, aged 18 to 45 years, inclusive;&#xD;
&#xD;
          3. The subject weighed at least 50.0 kg and had a body mass index (BMI) between 19.0&#xD;
             kg/m^2 and 24.0 kg/m^2, inclusive;&#xD;
&#xD;
          4. Has clinical laboratory evaluations, vital signs and ECG testing within the reference&#xD;
             range, and medical history and physicial examination results are normal. Participants&#xD;
             with evaluations outside the reference range that are deemed not clinically&#xD;
             significant by the investigator may be included at investigator discretion;&#xD;
&#xD;
          5. No medical history of allergy to proton pump inhibitors and no any other drug allergy&#xD;
             history;&#xD;
&#xD;
          6. The subjects have a good lifestyle and can keep good communication with the&#xD;
             investigators and comply with the requirements of clinical trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has postural hypotension, gastrointestinal disease (gastric ulcer, gastritis and etc),&#xD;
             liver disease, renal disease (nephritis, pyelonephritis and etc), and other disease or&#xD;
             medical history of any other system (cardiovascular, respiratory, psychoneural,&#xD;
             hematology, endocrinology and etc) ;&#xD;
&#xD;
          2. Has clinical significant abnormal electrolytes (especially hypopotassemia) in&#xD;
             screening examination;&#xD;
&#xD;
          3. Has clinical significant ECG abnormal history or family history of long QT&#xD;
             syndrome(Grandparents, parents and siblings);&#xD;
&#xD;
          4. Has rhinitis, allergic rhinitis, recurrent hemorrhinia, nasal deformity and abnormal&#xD;
             nasal septum；&#xD;
&#xD;
          5. With positive result of drug screening test;&#xD;
&#xD;
          6. With positive result of nicotine test;&#xD;
&#xD;
          7. Female participants who are pregnant, breast-feeding or menstral period, or&#xD;
             participants has no effective contraception method, or has pregnancy plan in 6 months;&#xD;
&#xD;
          8. Has received any drugs: acid-inhibitors, any priscription drug, herb medicine,&#xD;
             non-prescription drugs and/or food suppliments (including vitamine) within 2 weeks&#xD;
             before randomization;&#xD;
&#xD;
          9. Blood donation / blood loss ≥400 mL within 3 months, or participated any other&#xD;
             clinical trials within 3 months;&#xD;
&#xD;
         10. Known Human immunodeficiency virus antibody, hepatitis B surface antigen, hepatitis C&#xD;
             antibody, and Treponema pallidum specific antibody test results were positive at&#xD;
             screening;&#xD;
&#xD;
         11. Frequent alcoholics (drink more than 2 units of alcohol per day, 1 unit = 330 mL beer&#xD;
             or 25 mL liquor or 125 mL wine), or took food or drinks with alcoholics 72 hours&#xD;
             before randomization;&#xD;
&#xD;
         12. Has taken foods or drinks with xanthine(cafeine) or intensive excercise. Has taken&#xD;
             foods or drinks that affect CYP3A4 (such as grapefruit or beverages containing&#xD;
             grapefruit) within 14 days before administration of investigational drugs;&#xD;
&#xD;
         13. Smoke more than 5 pieces per week;&#xD;
&#xD;
         14. Any conditions in which considered by investigator not be appropriate to participate&#xD;
             in this trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</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/NCT04466748
org study id: 3571-CPK-1003
nct id: NCT04466748
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A single-center, randomized, double-blinded, placebo parallel controlled phase 1 study to
      evaluate the safety and pharmacokinetics/pharmacodynamics of multiple (6 days) ascending dose
      (20mg QD, 40mg QD, 20mg Bid) administrationof Anaprazole in healthy Chinese subjects. 36
      subjects, 12 subjects for each dose group. In each dose group, 10 subjects take anaprazole, 2
      subjects take placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of subjects with adverse events and serious adverse events as assessed by CTCAE v5.0
time frame: From signing informed consent to study completion, 15 days after fist dose administration
description: All adverse events will be monitored in each subject
measure: AUC of anaprazole (parent drug, KBP-3571) and its enantiomer（KBP-3570）and its major metabolites
time frame: 10 minutes pre-dose and 1.5、2、2.5、3、3.5、4、4.5、5、6、7、8、10、12、15、24 hours post-dose of Day 0 and Day 6
description: AUC is area under the plasma concentration-time curve
measure: Cmax of anaprazole (parent drug, KBP-3571) and its enantiomer（KBP-3570）and its major metabolites
time frame: 10 minutes pre-dose and 1.5、2、2.5、3、3.5、4、4.5、5、6、7、8、10、12、15、24 hours post-dose of Day 0 and Day 6
description: Cmax is the peak plasma concentration
measure: Tmax of anaprazole (parent drug, KBP-3571) and its enantiomer（KBP-3570）and its major metabolites
time frame: 10 minutes pre-dose and 1.5、2、2.5、3、3.5、4、4.5、5、6、7、8、10、12、15、24 hours post-dose of Day 0 and Day 6
description: Tmax is the time to peak plasma concentration
measure: Time percentage of gastric pH value>3 in 24 hours gastric pH monitoring post dose at day 6
time frame: 24 hours post-dose at day 6
description: Time percentage gastric pH value>3 is duration (hours) of gastric pH value>3 divided to 24 hours
measure: Time percentage of gastric pH value>4 in 24 hours gastric pH monitoring post dose at day 6
time frame: 24 hours post-dose at day 6
description: Time percentage gastric pH value>4 is duration (hours) of gastric pH value>3 divided to 24 hours
arm group label: Anaprazole Sodium enteric-coated tablet
arm group type: Experimental
description: "Multiple ascendinng dose, anaprazole 20mg QD(20mg QD group), 40mg QD(40mg QD group), 20mg Bid(20mg Bid group) , 6 days, fasting oral administration.
arm group label: Placebo
arm group type: Placebo Comparator
description: Multiple dose, 1 tablet QD (20mg QD and 40mg QD group), 1 tablet Bid (20mg Bid group), 6 days, fasting oral administration.
intervention type: Drug
intervention name: Anaprazole Sodium enteric-coated tablet
description: Multiple ascendinng dose, anaprazole 20mg QD(20mg QD group), 40mg QD(40mg QD group), 20mg Bid(20mg Bid group) , 6 days, fasting oral administration.
arm group label: Anaprazole Sodium enteric-coated tablet
intervention type: Drug
intervention name: Placebo
description: Multiple dose, 1 tablet QD (20mg QD and 40mg QD group), 1 tablet Bid (20mg Bid group), 6 days, fasting oral administration.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor