<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/NCT04467060</url>
  </required_header>
  <id_info>
    <org_study_id>3571-CPK-1001</org_study_id>
    <nct_id>NCT04467060</nct_id>
  </id_info>
  <brief_title>A Single 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 Pharmacology of Single 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, open-labeled, 2×2 crossover phase 1 study to evaluate the&#xD;
      pharmakinetics effect of high fat food to single dose administration of Anaprazole in healthy&#xD;
      Chinese male subjects. 14 health male subjects is divided to A group (n=7) and B group (n=7).&#xD;
      2 periods (7 days) cross-over design, anaprazole 40mg single dose, one is fasting oral&#xD;
      administration before breakfast, the other is oral administration 30 minutes after breakfast&#xD;
      with high fat food.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2014</start_date>
  <completion_date type="Actual">June 25, 2015</completion_date>
  <primary_completion_date type="Actual">June 25, 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, 8 days post-dose</time_frame>
    <description>All adverse events will be monitored in each subject</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Healthy Male Volunteers</condition>
  <arm_group>
    <arm_group_label>Anaprazole Sodium enteric-coated tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single ascendinng dose (2.5mg, 5mg, 10mg, 20mg, 40mg, 80mg, 120mg, 160mg), fasting oral administration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>single dose, fasting oral administration</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anaprazole Sodium</intervention_name>
    <description>2.5mg, 5mg, 10mg, 20mg, 40mg, 80mg, 120mg, 160mg，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>single dose, 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 25.0 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>June 2014</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/NCT04467060
org study id: 3571-CPK-1001
nct id: NCT04467060
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A single-center, randomized, open-labeled, 2×2 crossover phase 1 study to evaluate the
      pharmakinetics effect of high fat food to single dose administration of Anaprazole in healthy
      Chinese male subjects. 14 health male subjects is divided to A group (n=7) and B group (n=7).
      2 periods (7 days) cross-over design, anaprazole 40mg single dose, one is fasting oral
      administration before breakfast, the other is oral administration 30 minutes after breakfast
      with high fat food.
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, 8 days post-dose
description: All adverse events will be monitored in each subject
arm group label: Anaprazole Sodium enteric-coated tablet
arm group type: Experimental
description: Single ascendinng dose (2.5mg, 5mg, 10mg, 20mg, 40mg, 80mg, 120mg, 160mg), fasting oral administration.
arm group label: Placebo
arm group type: Placebo Comparator
description: single dose, fasting oral administration
intervention type: Drug
intervention name: Anaprazole Sodium
description: 2.5mg, 5mg, 10mg, 20mg, 40mg, 80mg, 120mg, 160mg，fasting oral administration.
arm group label: Anaprazole Sodium enteric-coated tablet
intervention type: Drug
intervention name: Placebo
description: single dose, 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