<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/NCT03235778</url>
  </required_header>
  <id_info>
    <org_study_id>CDP-2012-009</org_study_id>
    <nct_id>NCT03235778</nct_id>
  </id_info>
  <brief_title>A Phase I Clinical Study Trial of Felbinac Trometamol Injection in China</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalated Phase I Clinical Study Trial to Evaluate the Tolerance and Pharmacokinetics of Felbinac Trometamol Injection in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yiling Pharmaceutical Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yiling Pharmaceutical Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. To evaluate the tolerances of healthy subjects treated with Felbinac Trometamol&#xD;
           Injection on multiple dose and single dose&#xD;
&#xD;
        2. To evaluate the pharmacokinetic characteristics in healthy subjects treated with&#xD;
           Felbinac Trometamol Injection on multiple dose and single dose&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 17, 2017</start_date>
  <completion_date type="Actual">June 15, 2018</completion_date>
  <primary_completion_date type="Actual">March 19, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double-blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Tolerance evaluation index</measure>
    <time_frame>up to 48.5 hours</time_frame>
    <description>percent of subjects with adverse reactions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tmax</measure>
    <time_frame>up to 48.5 hours</time_frame>
    <description>The amount of time that a drug is present at the maximum concentration in serum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Plasma Concentration (Cmax)</measure>
    <time_frame>up to 48.5 hours</time_frame>
    <description>The PK parameters of the plasma sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2</measure>
    <time_frame>up to 48.5 hours</time_frame>
    <description>The PK parameters of the plasma sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vd</measure>
    <time_frame>up to 48.5 hours</time_frame>
    <description>The PK parameters of the plasma sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time (MRT) parameter.</measure>
    <time_frame>up to 48.5 hours</time_frame>
    <description>The PK parameters of the plasma sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ke</measure>
    <time_frame>up to 48.5 hours</time_frame>
    <description>The PK parameters of the plasma sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC0-∞)</measure>
    <time_frame>up to 48.5 hours</time_frame>
    <description>The PK parameters of the plasma sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-48.5</measure>
    <time_frame>up to 48.5 hours</time_frame>
    <description>The PK parameters of the plasma sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ae0-48.5</measure>
    <time_frame>up to 48.5 hours</time_frame>
    <description>The PK parameters of the urine and the stool sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fe</measure>
    <time_frame>up to 48.5 hours</time_frame>
    <description>The PK parameters of the urine and the stool sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CLr</measure>
    <time_frame>up to 48.5 hours</time_frame>
    <description>The PK parameters of the urine sample</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>group1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:11.78mg Volume:0.50ml Frequency:Once Duration:30min A total of 10 subjects, 2 subjects served as pre-test groups, given to the test drug；the remaining 8 subjects,6 received the test drug and 2 received the placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:23.56mg Volume:1.00ml Frequency:Once Duration:30min A total of 8 subjects,6 received the test drug and 2 received the placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:47.13mg Volume:2.00ml Frequency:Once Duration:30min A total of 8 subjects,6 received the test drug and 2 received the placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:94.25mg Volume:4.00ml Frequency:Once Duration:30min A total of 8 subjects,6 received the test drug and 2 received the placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:164.92mg Volume:7.00ml Frequency:Once Duration:30min A total of 8 subjects,6 received the test drug and 2 received the placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:259.16mg Volume:11.00ml Frequency:Once A total of 8 subjects,6 received the test drug and 2 received the placebo. Duration:30min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group7</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:377.00mg Volume:16.00ml Frequency:Once A total of 8 subjects,6 received the test drug and 2 received the placebo. Duration:30min</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Felbinac Trometamol Injection</intervention_name>
    <description>Felbinac Trometamol Injection will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump</description>
    <arm_group_label>group1</arm_group_label>
    <arm_group_label>group2</arm_group_label>
    <arm_group_label>group3</arm_group_label>
    <arm_group_label>group4</arm_group_label>
    <arm_group_label>group5</arm_group_label>
    <arm_group_label>group6</arm_group_label>
    <arm_group_label>group7</arm_group_label>
    <other_name>4-Biphenylacetic Acid Trishydroxymettiylaminometnane</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Normal saline will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump</description>
    <arm_group_label>group1</arm_group_label>
    <arm_group_label>group2</arm_group_label>
    <arm_group_label>group3</arm_group_label>
    <arm_group_label>group4</arm_group_label>
    <arm_group_label>group5</arm_group_label>
    <arm_group_label>group6</arm_group_label>
    <arm_group_label>group7</arm_group_label>
    <other_name>normal saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Sign the informed consent form before the trial and fully understand the contents of&#xD;
             the trial, the process and possible adverse reactions;&#xD;
&#xD;
          2. Be able to complete the research according to the clinical trial protocol;&#xD;
&#xD;
          3. Subjects have no pregnancy plan within the next 6 months and voluntarily take&#xD;
             effective contraceptive measures;&#xD;
&#xD;
          4. Male and female subjects between 18 and 45 years (inclusive) of age;&#xD;
&#xD;
          5. Male subjects weighing no less than 50 kg, female subjects weighing no less than 45&#xD;
             kg.Body Mass Index (BMI) 18 to 28 kg/m2 (inclusive);&#xD;
&#xD;
          6. Health status: no clinical histories with clinical significance about heart, liver,&#xD;
             kidney, digestive tract, nervous system, respiratory system (such as asthma), mental&#xD;
             disorders and metabolic abnormalities and so on;&#xD;
&#xD;
          7. Physical examination, vital signs normal or no clinical significance.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Someone smoking more than 5 pieces per day within the 3 months before the trial ；&#xD;
&#xD;
          2. Allergies, such as allergies to two or more drugs, food and pollen, or known to the&#xD;
             drug component or ethylbenzene ethyl acetate allergy;&#xD;
&#xD;
          3. Having a history of drug and / or alcohol abuse (14 units of alcohol per week: 1 units&#xD;
             = beer 285 mL, or 25 mL of spirits, or 100 mL of wine)；&#xD;
&#xD;
          4. Blood donation or extensive blood loss (&gt; 400 mL) within three months of the use of&#xD;
             the study drug;&#xD;
&#xD;
          5. Taked any drug that changes liver enzyme activity 28 days prior to the use of the&#xD;
             study drug;&#xD;
&#xD;
          6. Taked any prescription, OTC drugs, any vitamin products or herbs within 14 days prior&#xD;
             to the use of the study drug;&#xD;
&#xD;
          7. Two weeks before the trial took a special diet (including dragon fruit, mango,&#xD;
             grapefruit, and / or rich in xanthine diet, etc.) or strenuous exercise, and other&#xD;
             avtivites that affect drug absorption, distribution, metabolism, excretion and so on;&#xD;
&#xD;
          8. Combined with the following CYP3A4, p-gp or Bcrp inhibitors or inducers, such as&#xD;
             itraconazole, ketoconazole or dronedarone;&#xD;
&#xD;
          9. There have been significant changes in diet or exercise habits recently;&#xD;
&#xD;
         10. Taked research drugs within three months prior to the use of the study drug or&#xD;
             participating in any drug clinical trial;&#xD;
&#xD;
         11. Suffering from any increased risk of hemorrhagic disease, such as hemorrhoids, acute&#xD;
             gastritis or stomach and duodenal ulcers;&#xD;
&#xD;
         12. ECG has clinical significance;&#xD;
&#xD;
         13. Female subjects are in lactation or serum pregnancy test are positive during screening&#xD;
             or during the test.&#xD;
&#xD;
         14. Clinical laboratory tests are abnormal and have clinical significance, or other&#xD;
             clinical findings showing clinically significant diseases (including but not limited&#xD;
             to gastrointestinal, renal, liver, nerves, blood, endocrine, neoplasms, lungs,&#xD;
             immunizations, mental or heart Cerebrovascular disease);&#xD;
&#xD;
         15. hepatitis (including hepatitis B and hepatitis C), AIDS, syphilis screening test&#xD;
             positive;&#xD;
&#xD;
         16. Acute disease occurs before screening or using test drug;&#xD;
&#xD;
         17. Taking chocolate, any caffeine, or xanthine-rich food or drink at least 48 hours prior&#xD;
             to the use of the study drug;&#xD;
&#xD;
         18. Taking any alcoholic products within 24 hours prior to the use of the study drug;&#xD;
&#xD;
         19. Alcohol or drug screening positive or drug abuse history over the past five years or 3&#xD;
             months before the trial used by drug users.&#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_official>
    <last_name>Yanhua Ding, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Hospital of Jilin University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The First Hospital of Jilin University</name>
      <address>
        <city>Chang Chun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>November 14, 2019</last_update_submitted>
  <last_update_submitted_qc>November 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tolerance; Pharmacokinetic characteristics</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Biphenylylacetic acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03235778
org study id: CDP-2012-009
nct id: NCT03235778
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
1. To evaluate the tolerances of healthy subjects treated with Felbinac Trometamol
           Injection on multiple dose and single dose

        2. To evaluate the pharmacokinetic characteristics in healthy subjects treated with
           Felbinac Trometamol Injection on multiple dose and single dose
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double-blind
measure: Tolerance evaluation index
time frame: up to 48.5 hours
description: percent of subjects with adverse reactions
measure: Tmax
time frame: up to 48.5 hours
description: The amount of time that a drug is present at the maximum concentration in serum.
measure: Peak Plasma Concentration (Cmax)
time frame: up to 48.5 hours
description: The PK parameters of the plasma sample
measure: t1/2
time frame: up to 48.5 hours
description: The PK parameters of the plasma sample
measure: Vd
time frame: up to 48.5 hours
description: The PK parameters of the plasma sample
measure: Mean residence time (MRT) parameter.
time frame: up to 48.5 hours
description: The PK parameters of the plasma sample
measure: Ke
time frame: up to 48.5 hours
description: The PK parameters of the plasma sample
measure: Area under the plasma concentration versus time curve (AUC0-∞)
time frame: up to 48.5 hours
description: The PK parameters of the plasma sample
measure: AUC0-48.5
time frame: up to 48.5 hours
description: The PK parameters of the plasma sample
measure: Ae0-48.5
time frame: up to 48.5 hours
description: The PK parameters of the urine and the stool sample
measure: Fe
time frame: up to 48.5 hours
description: The PK parameters of the urine and the stool sample
measure: CLr
time frame: up to 48.5 hours
description: The PK parameters of the urine sample
arm group label: group1
arm group type: Experimental
description: Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:11.78mg Volume:0.50ml Frequency:Once Duration:30min A total of 10 subjects, 2 subjects served as pre-test groups, given to the test drug；the remaining 8 subjects,6 received the test drug and 2 received the placebo.
arm group label: group2
arm group type: Experimental
description: Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:23.56mg Volume:1.00ml Frequency:Once Duration:30min A total of 8 subjects,6 received the test drug and 2 received the placebo.
arm group label: group3
arm group type: Experimental
description: Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:47.13mg Volume:2.00ml Frequency:Once Duration:30min A total of 8 subjects,6 received the test drug and 2 received the placebo.
arm group label: group4
arm group type: Experimental
description: Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:94.25mg Volume:4.00ml Frequency:Once Duration:30min A total of 8 subjects,6 received the test drug and 2 received the placebo.
arm group label: group5
arm group type: Experimental
description: Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:164.92mg Volume:7.00ml Frequency:Once Duration:30min A total of 8 subjects,6 received the test drug and 2 received the placebo.
arm group label: group6
arm group type: Experimental
description: Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:259.16mg Volume:11.00ml Frequency:Once A total of 8 subjects,6 received the test drug and 2 received the placebo. Duration:30min
arm group label: group7
arm group type: Experimental
description: Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:377.00mg Volume:16.00ml Frequency:Once A total of 8 subjects,6 received the test drug and 2 received the placebo. Duration:30min
intervention type: Drug
intervention name: Felbinac Trometamol Injection
description: Felbinac Trometamol Injection will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump
arm group label: group1
arm group label: group2
arm group label: group3
arm group label: group4
arm group label: group5
arm group label: group6
arm group label: group7
other name: 4-Biphenylacetic Acid Trishydroxymettiylaminometnane
intervention type: Drug
intervention name: Placebo
description: Normal saline will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump
arm group label: group1
arm group label: group2
arm group label: group3
arm group label: group4
arm group label: group5
arm group label: group6
arm group label: group7
other name: normal saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yanhua Ding, MD
role: Principal Investigator
affiliation: The First Hospital of Jilin University
facility: 
country: China
responsible party type: Sponsor
mesh term: Biphenylylacetic acid
sharing ipd: No