<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/NCT04411875</url>
  </required_header>
  <id_info>
    <org_study_id>180815-ALDP-01</org_study_id>
    <nct_id>NCT04411875</nct_id>
  </id_info>
  <brief_title>Bioequivalence of Levamlodipine Besylate Tablets in Healthy Chinese Subjects</brief_title>
  <official_title>Bioequivalence of Levamlodipine Besylate Tablets in Healthy Chinese Subjects: A Single-dose and Two-period Crossover Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Affiliated Hospital of Qingdao University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Affiliated Hospital of Qingdao University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The single-dose randomized, open-label, two-period crossover study was executed in the Phase&#xD;
      I Clinical Research Center of the Affiliated Hospital of Qingdao University. According to the&#xD;
      random table generate by SAS 9.4, the subjects were divided into two groups at the ratio of&#xD;
      1:1. The select qualified volunteers were hospitalized in the Phase I Clinical Research&#xD;
      Center, and fasted for 10 hours overnight until administration. The medicine was swallowed&#xD;
      with 240 ml water at room temperature. Blood samples were taken before administration and at&#xD;
      1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168 hours after&#xD;
      administration. The samples were centrifuged at 1,800 g for 10 min at 4 °C to separate the&#xD;
      plasma. The plasma samples were divided into two aliquots and stored at -80 °C until&#xD;
      bioanalysis. The half-life of levamlodipine is 30 ~ 50 hours. Washout period, the interval&#xD;
      between two administration, is 21 days. In the two periods, the operation was kept the same.&#xD;
&#xD;
      Moreover, in high fat meal group, the high-fat breakfast was arranged within half an hour&#xD;
      before taking the medicine. Other procedures were the same as those in the fasting group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 13, 2018</start_date>
  <completion_date type="Actual">February 15, 2019</completion_date>
  <primary_completion_date type="Actual">January 15, 2019</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak Plasma Concentration (Cmax)</measure>
    <time_frame>64 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>64 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>64 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>64 days</time_frame>
    <description>Collection of adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of abnormal blood pressure</measure>
    <time_frame>64 days</time_frame>
    <description>Monitor both systolic and diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of abnormal temperature</measure>
    <time_frame>64 days</time_frame>
    <description>Monitor the temperature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of abnormal pulse</measure>
    <time_frame>64 days</time_frame>
    <description>Temperature the pulse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of abnormal electrocardiogram waveform</measure>
    <time_frame>64 days</time_frame>
    <description>Electrocardiogram inspection</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>Amlodipine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>amlodipine reference formulation at a single dose of 10 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Levamlodipine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>levamlodipine test formulation at a single dose of 5 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amlodipine 10 mg</intervention_name>
    <description>The subjects randomly received single oral administration of amlodipine 10 mg.</description>
    <arm_group_label>Amlodipine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levamlodipine 5 mg</intervention_name>
    <description>The subjects randomly received single oral administration of levamlodipine 5 mg.</description>
    <arm_group_label>Levamlodipine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female aged 18 and above.&#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>19 Years</minimum_age>
    <maximum_age>48 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>yu Cao, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>the study director of phase I clinical research center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Phase Ⅰ Clinical Research Center</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <zip>266003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>levamlodipine</keyword>
  <keyword>bioequivalence</keyword>
  <keyword>pharmacokinetics</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amlodipine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The technical achievements (including but not limited to patent right and thesis publishing right) involved in this trial, clinical research materials and achievements are owned by Zhejiang onlycom Pharmaceutical Co., Ltd. With the written consent of Zhejiang onlycom Pharmaceutical Co., Ltd., all partners have the right to publish academic papers, and the Affiliated Hospital of Qingdao University, a clinical research institution, has the right to exchange research results in academic conferences or journals.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>The data have been available on February 15, 2019. The duration has not been determined.</ipd_time_frame>
  </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/NCT04411875
org study id: 180815-ALDP-01
nct id: NCT04411875
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The single-dose randomized, open-label, two-period crossover study was executed in the Phase
      I Clinical Research Center of the Affiliated Hospital of Qingdao University. According to the
      random table generate by SAS 9.4, the subjects were divided into two groups at the ratio of
      1:1. The select qualified volunteers were hospitalized in the Phase I Clinical Research
      Center, and fasted for 10 hours overnight until administration. The medicine was swallowed
      with 240 ml water at room temperature. Blood samples were taken before administration and at
      1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168 hours after
      administration. The samples were centrifuged at 1,800 g for 10 min at 4 °C to separate the
      plasma. The plasma samples were divided into two aliquots and stored at -80 °C until
      bioanalysis. The half-life of levamlodipine is 30 ~ 50 hours. Washout period, the interval
      between two administration, is 21 days. In the two periods, the operation was kept the same.

      Moreover, in high fat meal group, the high-fat breakfast was arranged within half an hour
      before taking the medicine. Other procedures were the same as those in the fasting group.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Peak Plasma Concentration (Cmax)
time frame: 64 days
description: Evaluation of Peak Plasma Concentration (Cmax)
measure: Area under the plasma concentration versus time curve (AUC)0-t
time frame: 64 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: 64 days
description: Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
measure: Incidence of Treatment-Emergent Adverse Events
time frame: 64 days
description: Collection of adverse events
measure: Incidence of abnormal blood pressure
time frame: 64 days
description: Monitor both systolic and diastolic blood pressure
measure: Incidence of abnormal temperature
time frame: 64 days
description: Monitor the temperature
measure: Incidence of abnormal pulse
time frame: 64 days
description: Temperature the pulse
measure: Incidence of abnormal electrocardiogram waveform
time frame: 64 days
description: Electrocardiogram inspection
arm group label: Amlodipine
arm group type: Active Comparator
description: amlodipine reference formulation at a single dose of 10 mg
arm group label: Levamlodipine
arm group type: Experimental
description: levamlodipine test formulation at a single dose of 5 mg
intervention type: Drug
intervention name: Amlodipine 10 mg
description: The subjects randomly received single oral administration of amlodipine 10 mg.
arm group label: Amlodipine
intervention type: Drug
intervention name: Levamlodipine 5 mg
description: The subjects randomly received single oral administration of levamlodipine 5 mg.
arm group label: Levamlodipine
criteria: 
gender: All
minimum age: 19 Years
maximum age: 48 Years
healthy volunteers: Accepts Healthy Volunteers
last name: yu Cao, Doctor
role: Principal Investigator
affiliation: the study director of phase I clinical research center
facility: 
country: China
responsible party type: Sponsor
mesh term: Amlodipine
sharing ipd: Yes
ipd description: The technical achievements (including but not limited to patent right and thesis publishing right) involved in this trial, clinical research materials and achievements are owned by Zhejiang onlycom Pharmaceutical Co., Ltd. With the written consent of Zhejiang onlycom Pharmaceutical Co., Ltd., all partners have the right to publish academic papers, and the Affiliated Hospital of Qingdao University, a clinical research institution, has the right to exchange research results in academic conferences or journals.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: The data have been available on February 15, 2019. The duration has not been determined.