<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/NCT04438720</url>
  </required_header>
  <id_info>
    <org_study_id>Awk-2019-BE-03</org_study_id>
    <nct_id>NCT04438720</nct_id>
  </id_info>
  <brief_title>Bioequivalence of Extended Release Nifedipine Tablets in Healthy Chinese Subjects</brief_title>
  <official_title>Bioequivalence of Extended Release Nifedipine Tablets in Healthy Chinese Subjects: A Single-dose and Two-period Crossover Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cao Yu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Affiliated Hospital of Qingdao University</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>
      According to the relevant provisions of bioequivalence test, nifedipine sustained-release&#xD;
      tablets (test preparation, t, 30mg / tablet) provided by Guangzhou bostao controlled release&#xD;
      pharmaceutical Co., Ltd. were compared with Adalat ® GITS (reference preparation, R, 30mg /&#xD;
      tablet) produced by Bayer Pharma AG to evaluate the bioequivalence of single dose in healthy&#xD;
      subjects under fasting conditions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 25, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 9, 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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak Plasma Concentration (Cmax)</measure>
    <time_frame>60 days</time_frame>
    <description>Evaluation of Peak Plasma Concentration (Cmax)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC)0-t</measure>
    <time_frame>60 days</time_frame>
    <description>Evaluation of Area under the plasma concentration versus time curve (AUC)0-t</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC)0-∞</measure>
    <time_frame>60 days</time_frame>
    <description>Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>60 days</time_frame>
    <description>Collection of adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of abnormal blood pressure</measure>
    <time_frame>60 days</time_frame>
    <description>Monitor both systolic and diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of abnormal temperature</measure>
    <time_frame>60 days</time_frame>
    <description>Monitor the temperature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of abnormal pulse</measure>
    <time_frame>60 days</time_frame>
    <description>Temperature the pulse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of abnormal electrocardiogram waveform</measure>
    <time_frame>60 days</time_frame>
    <description>Electrocardiogram inspection</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Therapeutic Equivalency</condition>
  <arm_group>
    <arm_group_label>Extended Release Nifedipine Tablets（Adalat® GITS）</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Extended Release Nifedipine reference formulation at a single dose of 30 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Extended Release Nifedipine Tablets</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Extended Release Nifedipine test formulation at a single dose of 30 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Extended Release Nifedipine Tablets 30 mg</intervention_name>
    <description>The subjects randomly received single oral administration of extended release nifedipine tablets 30 mg.</description>
    <arm_group_label>Extended Release Nifedipine Tablets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Extended Release Nifedipine Tablets 30 mg (Adalat® GITS)</intervention_name>
    <description>The subjects randomly received single oral administration of extended release nifedipine tablets 30 mg.</description>
    <arm_group_label>Extended Release Nifedipine Tablets（Adalat® GITS）</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female aged 18-45.&#xD;
&#xD;
          -  The body mass index is in the range of 18.6-28.5 kg/m2 (including the critical value).&#xD;
             The weight of male is not less than 50.0 kg, and that of female is not less than 45.0&#xD;
             kg.&#xD;
&#xD;
          -  The following examination show that the indicators are normal or abnormal without&#xD;
             clinical significance. The examination including: Vital signs, physical examination,&#xD;
             blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological&#xD;
             tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV),&#xD;
             and syphilis virus, 12 lead ECG, breath test for alcohol, drug abuse test.&#xD;
&#xD;
          -  The subjects have no family planning within 3 months and could select contraceptive&#xD;
             method.&#xD;
&#xD;
          -  Before the study, all subjects have been informed of the study's purpose, protocal,&#xD;
             benefits, and risks, and signed the informed consent voluntarily.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Being allergy to the study medications, smoking, alcohol abuse.&#xD;
&#xD;
          -  Participation in another clinical trial within 3 months.&#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>Yu Cao</last_name>
    <phone>+86 18661809090</phone>
    <email>caoyu1767@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Phase I Clinical Research Center</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <zip>266003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>yu Cao, doctor</last_name>
      <phone>86 18661809090</phone>
      <email>caoyu1767@126.com</email>
    </contact>
    <contact_backup>
      <last_name>ye Tao, master</last_name>
      <phone>86 17853287551</phone>
      <email>taoye165298765@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>August 20, 2020</last_update_submitted>
  <last_update_submitted_qc>August 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The Affiliated Hospital of Qingdao University</investigator_affiliation>
    <investigator_full_name>Cao Yu</investigator_full_name>
    <investigator_title>Director, Head of Phase I clinical research center, Principal Investigator, Clinical Professor.</investigator_title>
  </responsible_party>
  <keyword>Extended Release Nifedipine Tablets</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nifedipine</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/NCT04438720
org study id: Awk-2019-BE-03
nct id: NCT04438720
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
According to the relevant provisions of bioequivalence test, nifedipine sustained-release
      tablets (test preparation, t, 30mg / tablet) provided by Guangzhou bostao controlled release
      pharmaceutical Co., Ltd. were compared with Adalat ® GITS (reference preparation, R, 30mg /
      tablet) produced by Bayer Pharma AG to evaluate the bioequivalence of single dose in healthy
      subjects under fasting conditions.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Peak Plasma Concentration (Cmax)
time frame: 60 days
description: Evaluation of Peak Plasma Concentration (Cmax)
measure: Area under the plasma concentration versus time curve (AUC)0-t
time frame: 60 days
description: Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
measure: Area under the plasma concentration versus time curve (AUC)0-∞
time frame: 60 days
description: Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
measure: Incidence of Treatment-Emergent Adverse Events
time frame: 60 days
description: Collection of adverse events
measure: Incidence of abnormal blood pressure
time frame: 60 days
description: Monitor both systolic and diastolic blood pressure
measure: Incidence of abnormal temperature
time frame: 60 days
description: Monitor the temperature
measure: Incidence of abnormal pulse
time frame: 60 days
description: Temperature the pulse
measure: Incidence of abnormal electrocardiogram waveform
time frame: 60 days
description: Electrocardiogram inspection
arm group label: Extended Release Nifedipine Tablets（Adalat® GITS）
arm group type: Active Comparator
description: Extended Release Nifedipine reference formulation at a single dose of 30 mg
arm group label: Extended Release Nifedipine Tablets
arm group type: Experimental
description: Extended Release Nifedipine test formulation at a single dose of 30 mg
intervention type: Drug
intervention name: Extended Release Nifedipine Tablets 30 mg
description: The subjects randomly received single oral administration of extended release nifedipine tablets 30 mg.
arm group label: Extended Release Nifedipine Tablets
intervention type: Drug
intervention name: Extended Release Nifedipine Tablets 30 mg (Adalat® GITS)
description: The subjects randomly received single oral administration of extended release nifedipine tablets 30 mg.
arm group label: Extended Release Nifedipine Tablets（Adalat® GITS）
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yu Cao
phone: +86 18661809090
email: caoyu1767@126.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: The Affiliated Hospital of Qingdao University
investigator full name: Cao Yu
investigator title: Director, Head of Phase I clinical research center, Principal Investigator, Clinical Professor.
mesh term: Nifedipine