<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/NCT03249753</url>
  </required_header>
  <id_info>
    <org_study_id>SPH3127-103</org_study_id>
    <nct_id>NCT03249753</nct_id>
  </id_info>
  <brief_title>The Effect of Food Intake on the Pharmacokinetic of Single Dose SPH3127 Tablets in Chinese Health Subjects</brief_title>
  <official_title>to Evaluate the Effect of Food Intake on the Pharmacokinetic of Single Dose SPH3127 Tablets in Chinese Health Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Pharmaceuticals Holding Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Pharmaceuticals Holding Co., 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>
      This study is a single-center, randomized, open, double-cycle and double-cross and&#xD;
      self-reflection phase Ic clinical trial, to evaluate effect and safety of high fat diet on&#xD;
      pharmacokinetics of SPH3127 tablets.&#xD;
&#xD;
      Two panels, each consisting of ten participants (The number of single-sex subjects is not&#xD;
      less than 1/3 of the total number) will be randomized to A or B groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants who are in panel A will receive a single dose of a SPH3127 tablets 200mg when&#xD;
      limosis, then fast 4h after dosing, and 72 hours later participants take the second dose of&#xD;
      SPH3127 200mg after a high-fat breakfast.&#xD;
&#xD;
      Participants who are in panel B will receive a single dose of a SPH3127 tablets 200mg after a&#xD;
      high-fat breakfast, then 72 hours later participants take the second dose of SPH3127 200mg&#xD;
      when limosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 23, 2017</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">September 30, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma area under curve（AUC）(0-∞) of SPH3127 3127</measure>
    <time_frame>Before dose, and at 0.17 hours、0.33h、0.5h、0.75h、1h、1.25h、1.5h、2h、4h、6h、8h、12h、24h hours after dose</time_frame>
    <description>to evaluate the area under curve（AUC）(0-∞) of SPH3127 by feeding</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Cmax of SPH3127</measure>
    <time_frame>Before dose, and at 0.17 hours、0.33h、0.5h、0.75h、1h、1.25h、1.5h、2h、4h、6h、8h、12h、24h hours after dose</time_frame>
    <description>to evaluate the Cmax of SPH3127 by feeding</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Tmax of SPH3127</measure>
    <time_frame>Before dose, and at 0.17 hours、0.33h、0.5h、0.75h、1h、1.25h、1.5h、2h、4h、6h、8h、12h、24h hours after dose</time_frame>
    <description>to evaluate the Tmax of SPH3127 by feeding</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent terminal half-life of SPH3127</measure>
    <time_frame>Before dose, and at 0.17 hours、0.33h、0.5h、0.75h、1h、1.25h、1.5h、2h、4h、6h、8h、12h、24h hours after dose</time_frame>
    <description>to evaluate the Apparent terminal half-life of SPH3127 by feeding</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events (AEs)</measure>
    <time_frame>Baseline to 10-13 days post last dose</time_frame>
    <description>Incidence and intensity of Adverse Events according to Common Toxicity Criteria (CTC version 4.03) associated with SPH3127</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in laboratory hematology values</measure>
    <time_frame>Baseline to 10-13 days post last dose</time_frame>
    <description>to evaluate the change from baseline in laboratory hematology values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in laboratory chemistry values</measure>
    <time_frame>Baseline to 10-13 days post last dose</time_frame>
    <description>to evaluate the Change from baseline in laboratory chemistry values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in ECG</measure>
    <time_frame>Baseline to 10-13 days post last dose</time_frame>
    <description>to evaluate the from baseline in ECG</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>SPH3127 200mg Panel A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who are in panel A will receive a single dose of a SPH3127 tablets 200mg when limosis, then fast 4h after dosing, and 72 hours later participants take the second dose of SPH3127 200mg after a high-fat breakfast.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SPH3127 200mg Panel B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who are in panel B will receive a single dose of a SPH3127 tablets 200mg after a high-fat breakfast, then 72 hours later participants take the second dose of SPH3127 200mg when limosis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SPH3127 200mg Panel A</intervention_name>
    <description>Participants who are in panel A will receive a single dose of a SPH3127 tablets 200mg when limosis, then fast 4h after dosing, and 72 hours later participants take the second dose of SPH3127 200mg after a high-fat breakfast.</description>
    <arm_group_label>SPH3127 200mg Panel A</arm_group_label>
    <other_name>SPH3127 is a new study drug for hypertension</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SPH3127 200mg Panel B</intervention_name>
    <description>Participants who are in panel B will receive a single dose of a SPH3127 tablets 200mg after a high-fat breakfast, then 72 hours later participants take the second dose of SPH3127 200mg when limosis.</description>
    <arm_group_label>SPH3127 200mg Panel B</arm_group_label>
    <other_name>SPH3127 is a new study drug for hypertension</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The body mass index is 19 ~ 26kg/m2 (including the critical value), which allows the&#xD;
             minimum weight of male to be 50kg (including the critical value) and 45kg (the&#xD;
             critical value) for women.&#xD;
&#xD;
          -  Before the study, participants have kown about the significance, potential benefits,&#xD;
             inconveniences and potential risks of the study and can follow the research's&#xD;
             procedure and already sign the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant who pregnancy, lactating women, and plan to get pregnant within six months&#xD;
             after the clinical trial&#xD;
&#xD;
          -  Participant who has significant abnormal physical examination, laboratory examination&#xD;
             results (such as: liver function examination - aspartate aminotransferase (AST) and&#xD;
             alanine aminotransferase (ALT) more than 1.5 times that of the upper limit of normal)&#xD;
&#xD;
          -  Participant who has a history of cardiovascular, liver, kidney, digestive tract,&#xD;
             nervous system, blood system, familial hematologic disease, abnormal thyroid function,&#xD;
             or mental abnormality&#xD;
&#xD;
          -  Participant who has drug allergy history, allergy constitution&#xD;
&#xD;
          -  Participant who took oral contraceptives within 6 weeks&#xD;
&#xD;
          -  Participant who used any drug (including Chinese herbal medicine) within 1 week&#xD;
&#xD;
          -  Participant who donated blood within 2 months&#xD;
&#xD;
          -  Participant who participated clinical trials of any drug in the past 3 months (as&#xD;
             subjects)&#xD;
&#xD;
          -  Participant who has any positive result of virus serology check : human&#xD;
             immunodeficiency virus antigen antibody (HIV Ag/Ab) and hepatitis c virus (HCV) -&#xD;
             Immunoglobulin G（IgG)antibody to IgG, hepatitis b surface antigen (HBsAg) and&#xD;
             treponema pallidum antibody (TP)&#xD;
&#xD;
          -  Participant who are smoking, drinking, drinking coffee, strong tea and drug abusers&#xD;
&#xD;
          -  Participant who the researchers believe that there are volunteers who are not suitable&#xD;
             for the study&#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>
  <location>
    <facility>
      <name>The capital medical university affiliated Beijing anzhen hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>November 11, 2021</last_update_submitted>
  <last_update_submitted_qc>November 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_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/NCT03249753
org study id: SPH3127-103
nct id: NCT03249753
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is a single-center, randomized, open, double-cycle and double-cross and
      self-reflection phase Ic clinical trial, to evaluate effect and safety of high fat diet on
      pharmacokinetics of SPH3127 tablets.

      Two panels, each consisting of ten participants (The number of single-sex subjects is not
      less than 1/3 of the total number) will be randomized to A or B groups.
Participants who are in panel A will receive a single dose of a SPH3127 tablets 200mg when
      limosis, then fast 4h after dosing, and 72 hours later participants take the second dose of
      SPH3127 200mg after a high-fat breakfast.

      Participants who are in panel B will receive a single dose of a SPH3127 tablets 200mg after a
      high-fat breakfast, then 72 hours later participants take the second dose of SPH3127 200mg
      when limosis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Plasma area under curve（AUC）(0-∞) of SPH3127 3127
time frame: Before dose, and at 0.17 hours、0.33h、0.5h、0.75h、1h、1.25h、1.5h、2h、4h、6h、8h、12h、24h hours after dose
description: to evaluate the area under curve（AUC）(0-∞) of SPH3127 by feeding
measure: Plasma Cmax of SPH3127
time frame: Before dose, and at 0.17 hours、0.33h、0.5h、0.75h、1h、1.25h、1.5h、2h、4h、6h、8h、12h、24h hours after dose
description: to evaluate the Cmax of SPH3127 by feeding
measure: Plasma Tmax of SPH3127
time frame: Before dose, and at 0.17 hours、0.33h、0.5h、0.75h、1h、1.25h、1.5h、2h、4h、6h、8h、12h、24h hours after dose
description: to evaluate the Tmax of SPH3127 by feeding
measure: Apparent terminal half-life of SPH3127
time frame: Before dose, and at 0.17 hours、0.33h、0.5h、0.75h、1h、1.25h、1.5h、2h、4h、6h、8h、12h、24h hours after dose
description: to evaluate the Apparent terminal half-life of SPH3127 by feeding
measure: Number of participants with adverse events (AEs)
time frame: Baseline to 10-13 days post last dose
description: Incidence and intensity of Adverse Events according to Common Toxicity Criteria (CTC version 4.03) associated with SPH3127
measure: Change from baseline in laboratory hematology values
time frame: Baseline to 10-13 days post last dose
description: to evaluate the change from baseline in laboratory hematology values
measure: Change from baseline in laboratory chemistry values
time frame: Baseline to 10-13 days post last dose
description: to evaluate the Change from baseline in laboratory chemistry values
measure: Change from baseline in ECG
time frame: Baseline to 10-13 days post last dose
description: to evaluate the from baseline in ECG
arm group label: SPH3127 200mg Panel A
arm group type: Experimental
description: Participants who are in panel A will receive a single dose of a SPH3127 tablets 200mg when limosis, then fast 4h after dosing, and 72 hours later participants take the second dose of SPH3127 200mg after a high-fat breakfast.
arm group label: SPH3127 200mg Panel B
arm group type: Experimental
description: Participants who are in panel B will receive a single dose of a SPH3127 tablets 200mg after a high-fat breakfast, then 72 hours later participants take the second dose of SPH3127 200mg when limosis.
intervention type: Drug
intervention name: SPH3127 200mg Panel A
description: Participants who are in panel A will receive a single dose of a SPH3127 tablets 200mg when limosis, then fast 4h after dosing, and 72 hours later participants take the second dose of SPH3127 200mg after a high-fat breakfast.
arm group label: SPH3127 200mg Panel A
other name: SPH3127 is a new study drug for hypertension
intervention type: Drug
intervention name: SPH3127 200mg Panel B
description: Participants who are in panel B will receive a single dose of a SPH3127 tablets 200mg after a high-fat breakfast, then 72 hours later participants take the second dose of SPH3127 200mg when limosis.
arm group label: SPH3127 200mg Panel B
other name: SPH3127 is a new study drug for hypertension
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor
mesh term: Hypertension