<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/NCT01679028</url>
  </required_header>
  <id_info>
    <org_study_id>T89-10-JP</org_study_id>
    <nct_id>NCT01679028</nct_id>
  </id_info>
  <brief_title>Dose-Escalate Study to Investigate the Safety and Tolerability of T89 in Japanese</brief_title>
  <official_title>Single- and Multiple- Dose-Escalation Study to Investigate the Safety and Tolerability of T89 in Japanese Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tasly Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Parexel</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Tasly Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to see how safe an investigational new drug (T89) is and how&#xD;
      well healthy Japanese subjects tolerate it when given two single doses and a multiple dose.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single centre, double-blind, randomized, placebo controlled, single- and multiple-&#xD;
      dose-escalation study.&#xD;
&#xD;
      After informed consent is obtained, subjects were evaluated with a medical history&#xD;
      questionnaire, physical examination, blood and urine collections for clinical laboratory&#xD;
      safety tests, urine drug screen, serum pregnancy test for each women, vital signs and ECG.&#xD;
      The subjects who fulfill the inclusion criteria but no exclusion criteria were provisionally&#xD;
      enrolled. For participation in this trial, subjects were instructed to avoid any&#xD;
      prescription, over-the-counter (OTC), and alternative / complementary medications or&#xD;
      significant changes in diet without advance permission from principal investigator. The&#xD;
      subjects were instructed to discontinue alcohol, caffeine and bromine containing&#xD;
      beverage/food. 20 subjects were enrolled and divided into three Groups: Group A, Group B and&#xD;
      Group C.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">October 2012</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>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Adverse Drug Events and Serious Adverse Events</measure>
    <time_frame>30 days (after first dosing)</time_frame>
    <description>the Incidence of Adverse Drug Events and serious adverse events</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Placebo Group A</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>150mg Placebo Single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>T89 Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>150mg T89 single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group B</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>300mg placebo single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>T89 Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>300mg T89 single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group C</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>225mg Placebo bid for 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>T89 Group C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>225mg T89 bid for 14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>T89 Group A</intervention_name>
    <description>150mg single dose on day 1</description>
    <arm_group_label>T89 Group A</arm_group_label>
    <other_name>Dantonic®</other_name>
    <other_name>Salvtonic®</other_name>
    <other_name>Compound Danshen Dripping Pills</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Group A</intervention_name>
    <description>150mg single dose</description>
    <arm_group_label>Placebo Group A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Group B</intervention_name>
    <description>300mg single dose</description>
    <arm_group_label>Placebo Group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>T89 Group B</intervention_name>
    <description>300mg single dose</description>
    <arm_group_label>T89 Group B</arm_group_label>
    <other_name>Dantonic®</other_name>
    <other_name>Salvtonic®</other_name>
    <other_name>Compound Danshen Dripping Pills</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Group C</intervention_name>
    <description>225mg bid</description>
    <arm_group_label>Placebo Group C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>T89 Group C</intervention_name>
    <description>225mg bid</description>
    <arm_group_label>T89 Group C</arm_group_label>
    <other_name>Dantonic®</other_name>
    <other_name>Salvtonic®</other_name>
    <other_name>Compound Danshen Dripping Pills</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male and female volunteers aged between 20-55 years.&#xD;
&#xD;
          2. First generation of Japanese, and live in the U.S.A. less than 5 years and maintained&#xD;
             Japanese lifestyle.&#xD;
&#xD;
          3. The body mass index between 18 and 30 kg/m2.&#xD;
&#xD;
          4. Willing to not take alcoholic beverages, and caffeine- and the bromine-containing&#xD;
             beverages and foods (e.g., tea, coffee, chocolate, cola, etc.) for the duration of the&#xD;
             study beginning at the screening visit.&#xD;
&#xD;
          5. ECG with no clinically significant abnormalities.&#xD;
&#xD;
          6. No clinically significant medical history.&#xD;
&#xD;
          7. Vital signs and laboratory tests with no clinically significant abnormalities.&#xD;
&#xD;
          8. Volunteers had not taken any medication that would interfere with the procedures or&#xD;
             interpretation of study data or compromise subject safety within 4 weeks prior to the&#xD;
             first dose, per principal investigator discretion.&#xD;
&#xD;
          9. Volunteers must understand and be willing, able and likely to comply with all study&#xD;
             procedures and restrictions.&#xD;
&#xD;
         10. Volunteers must be able to give voluntary written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of uncontrolled, clinically significant neurologic, cardiovascular,&#xD;
             haematological, pulmonary, hepatic, renal, metabolic, GI, urologic, immunologic,&#xD;
             endocrine or psychiatric disease.&#xD;
&#xD;
          2. Pregnant or nursing mother - Women of childbearing potential must have a negative&#xD;
             pregnancy test, not be breast feeding and be established on a method of contraception&#xD;
             that in the investigator's opinion is acceptable.&#xD;
&#xD;
          3. Have on-going other treatment or medicine that may interfere with T89 or&#xD;
             administration of similar medication within 2 weeks of entering study, per principal&#xD;
             investigator discretion.&#xD;
&#xD;
          4. Blood donor in recent 3 months.&#xD;
&#xD;
          5. Have taken part in other clinical trials involving administration of study medications&#xD;
             in the previous 1 month before participation.&#xD;
&#xD;
          6. Excessive alcohol use (habitually consumed more than 21 units of alcohol per week or&#xD;
             has a history of alcohol abuse as defined by DSM-IV-TR criteria (a unit of alcohol is&#xD;
             equal to 1 ounce of hard liquor, 5 ounces of wine or 8 ounces of beer within past two&#xD;
             years).&#xD;
&#xD;
          7. History or evidence of habitual use of tobacco or nicotine containing products within&#xD;
             3 months of Screening, with the exception of light smoking (up to 5 cigarettes per day&#xD;
             or the equivalent)&#xD;
&#xD;
          8. Known hypersensitivity to any of the ingredients of T89 or other relevant drug&#xD;
             allergy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jason GUO, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Tasly Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>California Clinical Trial Medical Group</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <results_first_submitted>May 6, 2014</results_first_submitted>
  <results_first_submitted_qc>November 16, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 24, 2014</results_first_posted>
  <last_update_submitted>November 16, 2014</last_update_submitted>
  <last_update_submitted_qc>November 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 24, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>T89 Safety in Healthy Japanese population</keyword>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study Initiation Date: Auguest 1st, 2012&#xD;
Study Completion Date: October 20th, 2012&#xD;
Location: Phase I clinical Study Center:&#xD;
California Clinical Trials Medical Group 1509 Wilson Terrace Glendale, CA 91206</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo Group A</title>
          <description>Placebo 150mg single dose</description>
        </group>
        <group group_id="P2">
          <title>T89 Group A</title>
          <description>T89 150mg single dose</description>
        </group>
        <group group_id="P3">
          <title>Placebo Group B</title>
          <description>Placebo 300mg single dose</description>
        </group>
        <group group_id="P4">
          <title>T89 Group B</title>
          <description>T89 300mg single dose</description>
        </group>
        <group group_id="P5">
          <title>Placebo Group C</title>
          <description>Placebo 225mg bid for 14 days</description>
        </group>
        <group group_id="P6">
          <title>T89 Group C</title>
          <description>T89 225mg bid for 14 days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Placebo Group A: 2 T89 Group A: 4 Placebo Group B: 2 T89 Group B: 4 Placebo Group C: 2 T89 Group C: 6</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo Group A</title>
          <description>Placebo 150mg single dose</description>
        </group>
        <group group_id="B2">
          <title>T89 Group A</title>
          <description>T89 150mg single dose</description>
        </group>
        <group group_id="B3">
          <title>Placebo Group B</title>
          <description>Placebo 300mg single dose</description>
        </group>
        <group group_id="B4">
          <title>T89 Group B</title>
          <description>T89 300mg single dose</description>
        </group>
        <group group_id="B5">
          <title>Placebo Group C</title>
          <description>Placebo 225mg bid for 14 days</description>
        </group>
        <group group_id="B6">
          <title>T89 Group C</title>
          <description>T89 225mg bid for 14 days</description>
        </group>
        <group group_id="B7">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="2"/>
            <count group_id="B4" value="4"/>
            <count group_id="B5" value="2"/>
            <count group_id="B6" value="6"/>
            <count group_id="B7" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27" spread="3"/>
                    <measurement group_id="B2" value="24" spread="2"/>
                    <measurement group_id="B3" value="24.5" spread="4.9"/>
                    <measurement group_id="B4" value="24" spread="2.2"/>
                    <measurement group_id="B5" value="47.5" spread="6.4"/>
                    <measurement group_id="B6" value="40.6" spread="9.9"/>
                    <measurement group_id="B7" value="32.5" spread="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incidence of Adverse Drug Events and Serious Adverse Events</title>
        <description>the Incidence of Adverse Drug Events and serious adverse events</description>
        <time_frame>30 days (after first dosing)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group A</title>
            <description>150 mg placebo; single dose</description>
          </group>
          <group group_id="O2">
            <title>T89 Group A</title>
            <description>150mg T89; Single dose</description>
          </group>
          <group group_id="O3">
            <title>Placebo Group B</title>
            <description>300mg Placebo; single dose</description>
          </group>
          <group group_id="O4">
            <title>T89 Group B</title>
            <description>300mg T89; single dose</description>
          </group>
          <group group_id="O5">
            <title>Placebo Group C</title>
            <description>225mg bid for 10 days</description>
          </group>
          <group group_id="O6">
            <title>T89 Group C</title>
            <description>T89 225mg bid for 10 days</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Adverse Drug Events and Serious Adverse Events</title>
          <description>the Incidence of Adverse Drug Events and serious adverse events</description>
          <units>adverse event</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="2"/>
                <count group_id="O6" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 days after the last dose.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo Group A</title>
          <description>150 mg Placebo Single dose</description>
        </group>
        <group group_id="E2">
          <title>T89 Group A</title>
          <description>150mg T89 single dose</description>
        </group>
        <group group_id="E3">
          <title>Placebo Group B</title>
          <description>300mg Placebo single dose</description>
        </group>
        <group group_id="E4">
          <title>T89 Group B</title>
          <description>300mg T89 single dose</description>
        </group>
        <group group_id="E5">
          <title>Placebo Group C</title>
          <description>Placebo 225mg bid for 14 days</description>
        </group>
        <group group_id="E6">
          <title>T89 Group C</title>
          <description>T89 225mf bid for 14 days</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>PI can be co-authored with sponsor for the publication but cannot publish the result solely.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Henry SUN</name_or_title>
      <organization>Tasly Pharmaceuticals, Inc.</organization>
      <phone>240-744-6225</phone>
      <email>henrysunusa@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01679028
org study id: T89-10-JP
nct id: NCT01679028
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to see how safe an investigational new drug (T89) is and how
      well healthy Japanese subjects tolerate it when given two single doses and a multiple dose.
This is a single centre, double-blind, randomized, placebo controlled, single- and multiple-
      dose-escalation study.

      After informed consent is obtained, subjects were evaluated with a medical history
      questionnaire, physical examination, blood and urine collections for clinical laboratory
      safety tests, urine drug screen, serum pregnancy test for each women, vital signs and ECG.
      The subjects who fulfill the inclusion criteria but no exclusion criteria were provisionally
      enrolled. For participation in this trial, subjects were instructed to avoid any
      prescription, over-the-counter (OTC), and alternative / complementary medications or
      significant changes in diet without advance permission from principal investigator. The
      subjects were instructed to discontinue alcohol, caffeine and bromine containing
      beverage/food. 20 subjects were enrolled and divided into three Groups: Group A, Group B and
      Group C.
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Investigator)
measure: Incidence of Adverse Drug Events and Serious Adverse Events
time frame: 30 days (after first dosing)
description: the Incidence of Adverse Drug Events and serious adverse events
arm group label: Placebo Group A
arm group type: Placebo Comparator
description: 150mg Placebo Single dose
arm group label: T89 Group A
arm group type: Experimental
description: 150mg T89 single dose
arm group label: Placebo Group B
arm group type: Placebo Comparator
description: 300mg placebo single dose
arm group label: T89 Group B
arm group type: Experimental
description: 300mg T89 single dose
arm group label: Placebo Group C
arm group type: Placebo Comparator
description: 225mg Placebo bid for 14 days
arm group label: T89 Group C
arm group type: Experimental
description: 225mg T89 bid for 14 days
intervention type: Drug
intervention name: T89 Group A
description: 150mg single dose on day 1
arm group label: T89 Group A
other name: Dantonic®
other name: Salvtonic®
other name: Compound Danshen Dripping Pills
intervention type: Drug
intervention name: Placebo Group A
description: 150mg single dose
arm group label: Placebo Group A
intervention type: Drug
intervention name: Placebo Group B
description: 300mg single dose
arm group label: Placebo Group B
intervention type: Drug
intervention name: T89 Group B
description: 300mg single dose
arm group label: T89 Group B
other name: Dantonic®
other name: Salvtonic®
other name: Compound Danshen Dripping Pills
intervention type: Drug
intervention name: Placebo Group C
description: 225mg bid
arm group label: Placebo Group C
intervention type: Drug
intervention name: T89 Group C
description: 225mg bid
arm group label: T89 Group C
other name: Dantonic®
other name: Salvtonic®
other name: Compound Danshen Dripping Pills
criteria: 
gender: All
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jason GUO, M.D.
role: Study Director
affiliation: Tasly Pharmaceuticals, Inc.
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 