<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/NCT04400123</url>
  </required_header>
  <id_info>
    <org_study_id>FMTN-I-103</org_study_id>
    <nct_id>NCT04400123</nct_id>
  </id_info>
  <brief_title>A Bioequivalence Study of Famitinib Malate on Healthy Chinese Volunteers</brief_title>
  <official_title>A Single-centre, Single-dose, Randomized, Open-label and Two-cycle Crossover Bioequivalence Study of Famitinib Malate Capsules in Old and New Formulation on Healthy Chinese Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu HengRui Medicine 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>
      The primary objective is to evaluate the bioequivalence of famitinib malate capsules in new&#xD;
      and old formulations after oral dose under fasted condition on healthy Chinese subjects.&#xD;
&#xD;
      The secondary objective is to evaluate the safety after famitinib malate capsules oral dose&#xD;
      on healthy Chinese subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 27, 2020</start_date>
  <completion_date type="Actual">July 18, 2020</completion_date>
  <primary_completion_date type="Actual">July 18, 2020</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>
    <intervention_model_description>Treatment group TR Intervention: Drug: famitinib malate, new formulation; Intervention: Drug: famitinib malate, old formulation.&#xD;
Treatment group RT Intervention: Drug: famitinib malate, old formulation; Intervention: Drug: famitinib malate, new formulation.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics parameter: Cmax</measure>
    <time_frame>through study completion, an average of 30 days</time_frame>
    <description>Peak plasma concentration （Cmax）</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics parameter: AUC</measure>
    <time_frame>through study completion, an average of 30 days</time_frame>
    <description>Area under the plasma concentration versus time curve（AUC）</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics parameter: Tmax</measure>
    <time_frame>through study completion, an average of 30 days</time_frame>
    <description>Time of maximum observed concentration (Tmax)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics parameter: t1/2</measure>
    <time_frame>through study completion, an average of 30 days</time_frame>
    <description>Half time (t1/2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics parameter: λz</measure>
    <time_frame>through study completion, an average of 30 days</time_frame>
    <description>First order elimination rate constant (λz)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of participants with treatment-related adverse events assessed by CTCAE V5.0</measure>
    <time_frame>through study completion, an average of 30 days</time_frame>
    <description>An adverse event is any untoward medical occurrence in the subjects or clinical study participants.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy Adult Subjects</condition>
  <arm_group>
    <arm_group_label>Treatment group TR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Drug: famitinib malate, new formulation; Intervention: Drug: famitinib malate, old formulation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment group RT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Drug: famitinib malate, old formulation; Intervention: Drug: famitinib malate, new formulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Famitinib malate</intervention_name>
    <description>TR group:&#xD;
The first period，the subjects will be administrated with Famitinib malate in new formulation, then conduct blood collection within 192h; 14 days washout；The second period，the subjects will be administrated with Famitinib malate in old formulation, then conduct blood collection within 192h.&#xD;
RT group:&#xD;
The first period，the subjects will be administrated with Famitinib malate in old formulation, then conduct blood collection within 192h; 14 days washout；The second period，the subjects will be administrated with Famitinib malate in new formulation, then conduct blood collection within 192h.</description>
    <arm_group_label>Treatment group RT</arm_group_label>
    <arm_group_label>Treatment group TR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male subjects aged 18~45 (including 18 and 45 years old);&#xD;
&#xD;
          2. Body weight ≥ 50kg, body mass index (BMI) within the range of 19 ~ 26kg/m2 (including&#xD;
             19 and 26 kg/m2) (BMI= weight (kg)/height 2 (m2));&#xD;
&#xD;
          3. Consent to abstinence or take effective non-drug contraception measures during the&#xD;
             study and for at least 3 months after the last drug administration.&#xD;
&#xD;
          4. The subjects were able to communicate well with the researchers, understand and comply&#xD;
             with the requirements of this study, understand and sign the informed consent;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Anyone who has suffered from any clinical serious disease such as the circulatory&#xD;
             system, endocrine system, nervous system, digestive system, respiratory system,&#xD;
             urogenital system, hematology, immunology, psychiatry and metabolic abnormalities, or&#xD;
             any other disease which can affect the study results.&#xD;
&#xD;
          2. Those who have undergone surgery within 6 months before the trial, or plan to perform&#xD;
             surgery during the study period;&#xD;
&#xD;
          3. Those who donated blood or suffered heavy blood loss (≥200 mL), received blood&#xD;
             transfusions, or used blood products within 3 months before enrollment;&#xD;
&#xD;
          4. Have a history of allergies to drugs, food or other substances;&#xD;
&#xD;
          5. Have taken sedatives, sleeping pills or other addictive medicines within 1 year before&#xD;
             the study; Those with positive results in urine drug abuse screening;&#xD;
&#xD;
          6. Those who have participated in any clinical trials and have taken study drugs within 3&#xD;
             months before the first administration;&#xD;
&#xD;
          7. Those who have taken any medicine within 4 weeks before the first administration&#xD;
             (including prescription medicines, non-prescription medicines, Chinese herbal&#xD;
             medicines, vitamins, calcium tablets and other food supplements);&#xD;
&#xD;
          8. Those who smoked more than 5 cigarettes per day within 3 months before the study and&#xD;
             who could not stop using any tobacco products during the study;&#xD;
&#xD;
          9. Regular drinkers within 6 months before the test, that is, drinking more than 14 units&#xD;
             of alcohol per week (1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine),&#xD;
             and any alcohol-containing products cannot be stopped during the study Those who are&#xD;
             positive for alcohol breath test;&#xD;
&#xD;
         10. Those with any abnormal result (clinically significant) of vital signs, physical&#xD;
             examination, 12-lead electrocardiogram, chest radiograph, abdominal ultrasound, colour&#xD;
             Doppler echocardiography, hematology, clinical chemistry, urinalysis and coagulation;&#xD;
&#xD;
         11. Hepatitis B virus surface antigen is positive, or hepatitis C virus antibody is&#xD;
             positive, or treponema pallidum antibody is positive, or human immunodeficiency virus&#xD;
             antibody is positive;&#xD;
&#xD;
         12. The subject refuses to stop any beverage or food containing methylxanthine, such as&#xD;
             coffee, tea, cola, chocolate, etc., within 48 hours before the first dose until the&#xD;
             end of the study; The subject refuses to stop any beverage or food containing&#xD;
             grapefruit; Those who have special dietary requirements and cannot accept the unified&#xD;
             diet;&#xD;
&#xD;
         13. Other factors of the subject that are not suitable for participating in the study&#xD;
             judged by the investigators.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Xuanwu Hospital Beijing, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>October 19, 2021</last_update_submitted>
  <last_update_submitted_qc>October 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bioequivalence</keyword>
  <keyword>Old formulation</keyword>
  <keyword>New formulation</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04400123
org study id: FMTN-I-103
nct id: NCT04400123
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The primary objective is to evaluate the bioequivalence of famitinib malate capsules in new
      and old formulations after oral dose under fasted condition on healthy Chinese subjects.

      The secondary objective is to evaluate the safety after famitinib malate capsules oral dose
      on healthy Chinese subjects.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Treatment group TR Intervention: Drug: famitinib malate, new formulation; Intervention: Drug: famitinib malate, old formulation.
Treatment group RT Intervention: Drug: famitinib malate, old formulation; Intervention: Drug: famitinib malate, new formulation.
primary purpose: Basic Science
masking: None (Open Label)
measure: Pharmacokinetics parameter: Cmax
time frame: through study completion, an average of 30 days
description: Peak plasma concentration （Cmax）
measure: Pharmacokinetics parameter: AUC
time frame: through study completion, an average of 30 days
description: Area under the plasma concentration versus time curve（AUC）
measure: Pharmacokinetics parameter: Tmax
time frame: through study completion, an average of 30 days
description: Time of maximum observed concentration (Tmax)
measure: Pharmacokinetics parameter: t1/2
time frame: through study completion, an average of 30 days
description: Half time (t1/2)
measure: Pharmacokinetics parameter: λz
time frame: through study completion, an average of 30 days
description: First order elimination rate constant (λz)
measure: The number of participants with treatment-related adverse events assessed by CTCAE V5.0
time frame: through study completion, an average of 30 days
description: An adverse event is any untoward medical occurrence in the subjects or clinical study participants.
arm group label: Treatment group TR
arm group type: Experimental
description: Intervention: Drug: famitinib malate, new formulation; Intervention: Drug: famitinib malate, old formulation.
arm group label: Treatment group RT
arm group type: Experimental
description: Intervention: Drug: famitinib malate, old formulation; Intervention: Drug: famitinib malate, new formulation.
intervention type: Drug
intervention name: Famitinib malate
description: TR group:
The first period，the subjects will be administrated with Famitinib malate in new formulation, then conduct blood collection within 192h; 14 days washout；The second period，the subjects will be administrated with Famitinib malate in old formulation, then conduct blood collection within 192h.
RT group:
The first period，the subjects will be administrated with Famitinib malate in old formulation, then conduct blood collection within 192h; 14 days washout；The second period，the subjects will be administrated with Famitinib malate in new formulation, then conduct blood collection within 192h.
arm group label: Treatment group RT
arm group label: Treatment group TR
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor
sharing ipd: Undecided