<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/NCT03771781</url>
  </required_header>
  <id_info>
    <org_study_id>CTTQ-BE-2018-EGLJ</org_study_id>
    <nct_id>NCT03771781</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study of Empagliflozin Tablet in Healthy Participants.</brief_title>
  <official_title>A Single-Center, Open-Label, Randomized, Single-Dose, Two-Period, Two-Sequence, Crossover Study to Assess the Bioequivalence of Test Formulation With Reference Formulation in Healthy Adult Subjects.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chia Tai Tianqing Pharmaceutical Group Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chia Tai Tianqing Pharmaceutical Group Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bioequivalence Study of Empagliflozin Tablets and Jardiance® Under Fasting and Fed Conditions&#xD;
      in Chinese Healthy Volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Single-Center,Open-Label,Randomized,Single-Dose,Two-Period,Two-Sequence,Crossover Study to&#xD;
      Assess the Bioequivalence of Test Formulation Empagliflozin Tablets with Reference&#xD;
      Formulation Jardiance® in Chinese Healthy Adult Subjects under Fasting and Fed Conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 16, 2018</start_date>
  <completion_date type="Actual">May 25, 2018</completion_date>
  <primary_completion_date type="Actual">May 25, 2018</primary_completion_date>
  <phase>N/A</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>Peak Plasma Concentration (Cmax)</measure>
    <time_frame>0hours、0.67hours、1hours、1.5hours、2hours、2.5hours、3hours、4hours、6hours、8hours、12hours、24hours、36hours、48hours、72hours</time_frame>
    <description>Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curves (AUC)</measure>
    <time_frame>0hours、0.67hours、1hours、1.5hours、2hours、2.5hours、3hours、4hours、6hours、8hours、12hours、24hours、36hours、48hours、72hours</time_frame>
    <description>Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Empagliflozin Tablets</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The test formulation is manufactured by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd.During the study session,subjects will be administered a single does of Empagliflozin Tablets 25mg after fasting and fed conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Empagliflozin Tab 25 MG</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The reference formulation is manufactured by Boehringer Ingelheim International GmbH.During the study session,subjects will be administered a single does of Empagliflozin Tab 25 MG after fasting and fed conditions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Empagliflozin Tablets</intervention_name>
    <description>Observe the safty and PK after subjects receiving a single dose of Empagliflozin Tablets.</description>
    <arm_group_label>Empagliflozin Tablets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Empagliflozin Tab 25 MG</intervention_name>
    <description>Observe the safty and PK after subjects receiving a single dose of Empagliflozin Tablets( Jardiance®）.</description>
    <arm_group_label>Empagliflozin Tab 25 MG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male or female, age 18 to 50 years, inclusive.&#xD;
&#xD;
          2. The body weight of male is not less than 50kg, and female is not less than 45kg. All&#xD;
             participants' body mass index (BMI) is between 19~26.&#xD;
&#xD;
          3. Subjects are fully informed and voluntarily consent to participate in this study.&#xD;
&#xD;
          4. Volunteers can communicate well with researchers and comply with the requirements of&#xD;
             this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any with chronic or active gastrointestinal diseases such as esophageal diseases,&#xD;
             gastritis, gastric ulcers, enteritis, active gastrointestinal bleeding or got any&#xD;
             digestive tract surgery within three years.&#xD;
&#xD;
          2. Any disease previously or currently suffering from circulatory system, endocrine&#xD;
             system, nervous system, digestive system, respiratory system, hematology, immunology,&#xD;
             psychiatry, and metabolic abnormalities, and which the researchers believe can&#xD;
             interfere with the results of the test.&#xD;
&#xD;
          3. Any history of allergy to drugs, food, or other substances.&#xD;
&#xD;
          4. Dysphagia, difficulty in collecting blood or halo needle, history of dizziness.&#xD;
&#xD;
          5. Those who have undergone surgery during the first four weeks of the trial or are&#xD;
             scheduled to perform surgery during the study period.&#xD;
&#xD;
          6. Those who has taken any drug (including vitamin products, Chinese herbs) within 14&#xD;
             days before the study.&#xD;
&#xD;
          7. Those who use any inhibits or induces hepatic metabolism within 30 days before the&#xD;
             study.&#xD;
&#xD;
          8. Those who participated in any clinical drug trial within 3 months prior to the trial.&#xD;
&#xD;
          9. Those who donated or lose massive blood within 3 months before the study (&gt; 450 ml).&#xD;
&#xD;
         10. Pregnant and lactating women.&#xD;
&#xD;
         11. Male subjects (or their partners) or female subjects had unprotected sex or pregnancy&#xD;
             plans within 2 weeks before screening and 6 months after the end of the trial, Those&#xD;
             who are unwilling to use one or more non-drug contraceptive methods (e. G. Complete&#xD;
             abstinence, contraceptive ring, partner ligation, etc.) during the study.&#xD;
&#xD;
         12. Drug abusers or those who have used soft drugs for 3 months before the trial or who&#xD;
             took hard drugs one year before the study.&#xD;
&#xD;
         13. Those who has special requirements for diet and is unable to follow a uniform diet.&#xD;
&#xD;
         14. Smokers or those who smoked more than 5 cigarettes a day 3 months before the study.&#xD;
&#xD;
         15. An alcoholic or regular drinker for six months before the study, that is, a person who&#xD;
             drinks more than 14 units of alcohol a week.&#xD;
&#xD;
         16. People who drink excessive amounts of tea, coffee and/or caffeinated beverages (more&#xD;
             than 8 cups, 1 cup =250 mL) per day or who do not agree to stop drinking tea, coffee&#xD;
             and/or caffeinated beverages during the study period.&#xD;
&#xD;
         17. Those who take drug or food which may affect the drug metabolism(including grapefruit&#xD;
             or grapefruit products, dragon fruit, mango, pomelo, orange, yellow purine diet).Or&#xD;
             the researchers think that there are other affect drug absorption, distribution,&#xD;
             metabolism and excretion of diet.Or refuse to stop eating the diet during the study.&#xD;
&#xD;
         18. Those with abnormal physical examination, electrocardiogram, laboratory examination,&#xD;
             vital signs and test related examination with clinical significance .&#xD;
&#xD;
         19. Those who has vital signs with clinical significance, positive urine screening test,&#xD;
             positive alcohol breath test or positive female urine pregnancy.&#xD;
&#xD;
         20. Those who has acute illness or concomitant medication occurred before participating in&#xD;
             the study.&#xD;
&#xD;
         21. Other reasons which,in the opinion of the medical investigator,would prevent the&#xD;
             subject from participating in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Third Hospital of Changsha</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 9, 2018</study_first_submitted>
  <study_first_submitted_qc>December 9, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>February 20, 2019</last_update_submitted>
  <last_update_submitted_qc>February 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Empagliflozin</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/NCT03771781
org study id: CTTQ-BE-2018-EGLJ
nct id: NCT03771781
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Bioequivalence Study of Empagliflozin Tablets and Jardiance® Under Fasting and Fed Conditions
      in Chinese Healthy Volunteers.
A Single-Center,Open-Label,Randomized,Single-Dose,Two-Period,Two-Sequence,Crossover Study to
      Assess the Bioequivalence of Test Formulation Empagliflozin Tablets with Reference
      Formulation Jardiance® in Chinese Healthy Adult Subjects under Fasting and Fed Conditions.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Peak Plasma Concentration (Cmax)
time frame: 0hours、0.67hours、1hours、1.5hours、2hours、2.5hours、3hours、4hours、6hours、8hours、12hours、24hours、36hours、48hours、72hours
description: Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data.
measure: Area under the plasma concentration versus time curves (AUC)
time frame: 0hours、0.67hours、1hours、1.5hours、2hours、2.5hours、3hours、4hours、6hours、8hours、12hours、24hours、36hours、48hours、72hours
description: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.
arm group label: Empagliflozin Tablets
arm group type: Other
description: The test formulation is manufactured by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd.During the study session,subjects will be administered a single does of Empagliflozin Tablets 25mg after fasting and fed conditions.
arm group label: Empagliflozin Tab 25 MG
arm group type: Other
description: The reference formulation is manufactured by Boehringer Ingelheim International GmbH.During the study session,subjects will be administered a single does of Empagliflozin Tab 25 MG after fasting and fed conditions.
intervention type: Drug
intervention name: Empagliflozin Tablets
description: Observe the safty and PK after subjects receiving a single dose of Empagliflozin Tablets.
arm group label: Empagliflozin Tablets
intervention type: Drug
intervention name: Empagliflozin Tab 25 MG
description: Observe the safty and PK after subjects receiving a single dose of Empagliflozin Tablets( Jardiance®）.
arm group label: Empagliflozin Tab 25 MG
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor
mesh term: Empagliflozin