<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/NCT03791463</url>
  </required_header>
  <id_info>
    <org_study_id>SAA002</org_study_id>
    <nct_id>NCT03791463</nct_id>
  </id_info>
  <brief_title>Effect of Food on Pharmacokinetics of Salvianolic Acid A in Healthy Subjects</brief_title>
  <official_title>A Phase I, Single Centre, Randomized, Open-Label, Three-Period Crossover Study to Investigate the Effect of Food on Pharmacokinetics of Salvianolic Acid A in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University First Hospital</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 an open-label, randomized, cross-over design with two single-dose treatment&#xD;
      periods and a washout of at least 3~5 days in between each treatment visit. The study period&#xD;
      consists of 3 visits to the study centre: Visit 1 (enrolment), Visit 2 (first single-dose&#xD;
      treatment), Visit 3 (second single-dose treatment).&#xD;
&#xD;
      Target subject population is healthy subjects aged 18-45 years. Following an overnight fast&#xD;
      of at least 10 hours, a single dose of 90mg salvianolic acid A will be administered on 3&#xD;
      separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion&#xD;
      with different food restrictions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Anticipated">January 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Effect of Food Timing (Fasting and After Meal) on Pharmacokinetics of salvianolic acid A in Healthy Subject</measure>
    <time_frame>Hour 24</time_frame>
    <description>To assess the effect of food by evaluating the area under the plasma concentration versus time curve, from time zero to the time of the last quantifiable analyte concentration (AUC(0-last))</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">14</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>After meal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject will receive a single oral dose of 90 mg salvianolic acid A. Each dose will be administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fasting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject will receive a single oral dose of 90 mg salvianolic acid A. Each dose will be administered at the end of a 10-hour fast.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>salvianolic acid A</intervention_name>
    <description>Following an overnight fast of at least 10 hours, a single dose of 90 mg salvianolic acid A will be administered on 2 separate occasions (fasting and after meal) in a randomized crossover fashion with different food restrictions.</description>
    <arm_group_label>After meal</arm_group_label>
    <arm_group_label>Fasting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body&#xD;
             mass index ≥19.0 and ≤25.0 kg/m2 at screening&#xD;
&#xD;
          2. The subject is able to communicate well with the investigator and is able to complete&#xD;
             the trial in accordance with the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Planned for pregnancy or pregnant within 6 months after enrollment throughout the&#xD;
             trial.&#xD;
&#xD;
          2. Subject has any clinically significant abnormal finding on the physical exam at&#xD;
             screening or admission.&#xD;
&#xD;
          3. Subject has a positive screening test for alcohol or drugs of abuse at screening or&#xD;
             admission.&#xD;
&#xD;
          4. Allergic to the body.&#xD;
&#xD;
          5. Participated in any clinical trial within 3 months prior to the 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>
  <overall_contact>
    <last_name>Yimin Cui, Ph.D</last_name>
    <phone>010-66110802</phone>
    <email>cuiymzy@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Xiaocong Pang</name>
      <address>
        <city>Beijing</city>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaocong Pang</last_name>
      <email>pangxiaocong1227@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>December 28, 2018</last_update_submitted>
  <last_update_submitted_qc>December 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University First Hospital</investigator_affiliation>
    <investigator_full_name>Cui Yimin</investigator_full_name>
    <investigator_title>Director of pharmacy, M.D &amp; Ph.D</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Salvianolic acid A</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/NCT03791463
org study id: SAA002
nct id: NCT03791463
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is an open-label, randomized, cross-over design with two single-dose treatment
      periods and a washout of at least 3~5 days in between each treatment visit. The study period
      consists of 3 visits to the study centre: Visit 1 (enrolment), Visit 2 (first single-dose
      treatment), Visit 3 (second single-dose treatment).

      Target subject population is healthy subjects aged 18-45 years. Following an overnight fast
      of at least 10 hours, a single dose of 90mg salvianolic acid A will be administered on 3
      separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion
      with different food restrictions.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The Effect of Food Timing (Fasting and After Meal) on Pharmacokinetics of salvianolic acid A in Healthy Subject
time frame: Hour 24
description: To assess the effect of food by evaluating the area under the plasma concentration versus time curve, from time zero to the time of the last quantifiable analyte concentration (AUC(0-last))
arm group label: After meal
arm group type: Experimental
description: Each subject will receive a single oral dose of 90 mg salvianolic acid A. Each dose will be administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake).
arm group label: Fasting
arm group type: Experimental
description: Each subject will receive a single oral dose of 90 mg salvianolic acid A. Each dose will be administered at the end of a 10-hour fast.
intervention type: Drug
intervention name: salvianolic acid A
description: Following an overnight fast of at least 10 hours, a single dose of 90 mg salvianolic acid A will be administered on 2 separate occasions (fasting and after meal) in a randomized crossover fashion with different food restrictions.
arm group label: After meal
arm group label: Fasting
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yimin Cui, Ph.D
phone: 010-66110802
email: cuiymzy@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University First Hospital
investigator full name: Cui Yimin
investigator title: Director of pharmacy, M.D & Ph.D
mesh term: Salvianolic acid A