<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/NCT04438733</url>
  </required_header>
  <id_info>
    <org_study_id>TG1914ANA</org_study_id>
    <nct_id>NCT04438733</nct_id>
  </id_info>
  <brief_title>Bioequivalence of Oral Formulations of Anastrozole in Healthy Chinese Volunteers Under Fasted Condition</brief_title>
  <official_title>Bioequivalence of Oral Formulations of Anastrozole in Healthy Chinese Volunteers Under Fasted Condition: A Open-label, Randomized,Single-dose,Two-period, Two-group, 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>
      An open-label, randomized, two-period, two-group, crossover study was conducted in 26 healthy&#xD;
      Chinese volunteers under fasted conditions to assess the bioequivalence between two&#xD;
      formulations of Anastrozole.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anastrozole is currently used as first-line treatment in locally advanced or metastatic&#xD;
      breast cancer. A generic anastrozole tablet was developed to offer an alternative to the&#xD;
      marketed tablet formulation.The aim of the current study was to evaluate the bioequivalence&#xD;
      between the test and reference formulations of anastrozole in a single-dose, 2-period,&#xD;
      2-sequence crossover study with a 21-day washout interval. A total of 26 healthy Chinese&#xD;
      female volunteers were enrolled and completed the study, after oral administration of a&#xD;
      single dose of 1.0-mg test and reference formulations of anastrozole. Blood samples (3 mL)&#xD;
      for pharmacokinetic analysis were collected predose and 20min, 40min, 1, 1h20min, 1h40min, 2,&#xD;
      2h20min, 2h40min, 3, 3.5, 4, 7, 12, 24, 48, and 72 hours postdose and were determined by a&#xD;
      fully validated high-pressure liquid chromatography-tandem mass spectrometry method. The&#xD;
      evaluated pharmacokinetic parameters, including Cmax, AUC0-t, AUC0-∞, were assessed for&#xD;
      bioequivalence based on current guidelines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 18, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 3, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the ratios of geometrical mean</measure>
    <time_frame>31 days</time_frame>
    <description>The two preparations were considered bioequivalent if the 90% CIs of the ratios of the primary pharmacokinetics parameters were within the predefined acceptance range of 80%-125%.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">26</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>test-anastrozole tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 mg anastrozole was produced and provided by Salutas Pharma GmbH</description>
  </arm_group>
  <arm_group>
    <arm_group_label>reference-anastrozole tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 mg anastrozole was produced by AstraZeneca Pharmaceuticals LP.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>test-anastrozole tablet (Salutas Pharma GmbH)</intervention_name>
    <description>Subjects were allocated to one of two groups randomly and equally with a 21-day washout interval between the two periods.All of them were randomized (1:1) to receive anastrozole as a single oral dose of the test drug or a single 1.0-mg oral dose of Arimidex</description>
    <arm_group_label>test-anastrozole tablet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>reference-anastrozole tablet (Arimidex)</intervention_name>
    <description>Subjects were allocated to one of two groups randomly and equally with a 21-day washout interval between the two periods.All of them were randomized (1:1) to receive anastrozole as a single oral dose of the test drug or a single 1.0-mg oral dose of Arimidex</description>
    <arm_group_label>reference-anastrozole tablet</arm_group_label>
    <other_name>Arimidex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Postmenopausal volunteers aged between 18 and 65 years old.&#xD;
&#xD;
          -  The body mass index is in the range of 19.0-28.0 kg/m2 (including the critical value).&#xD;
             The weight is not less than 45 kg.&#xD;
&#xD;
          -  The subjects have no family planning within 6 months and could select contraceptive&#xD;
             method.&#xD;
&#xD;
          -  Subjects who had not any medical history of cardiovascular, digestive, respiratory,&#xD;
             nervous, haemal diseases or hepatic/renal impairment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Meet the diagnostic criteria for osteoporosis.&#xD;
&#xD;
          -  Subjects with vaginal bleeding.&#xD;
&#xD;
          -  blood donation, massive blood loss (#400mL) or enrolled in other clinical trials 3&#xD;
             months prior to screening.&#xD;
&#xD;
          -  any use of other prescription drugs (including contraceptive) 28 days prior to&#xD;
             medication for this study.&#xD;
&#xD;
          -  any history of alcohol abuse in the recent 2 years or moderate drinkers (drink more 2&#xD;
             units per day or 14 units per week);&#xD;
&#xD;
          -  smoking more than 5 cigarettes per day during the 3 months prior to screening;&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 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>
  <overall_contact>
    <last_name>yu Cao, doctor</last_name>
    <phone>86 18661809090</phone>
    <email>caoyu1767@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>ye Tao, master</last_name>
    <phone>86 17853287551</phone>
    <email>taoye165298765@163.com</email>
  </overall_contact_backup>
  <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>June 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 27, 2020</last_update_submitted>
  <last_update_submitted_qc>June 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</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>Anastrozole</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/NCT04438733
org study id: TG1914ANA
nct id: NCT04438733
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
An open-label, randomized, two-period, two-group, crossover study was conducted in 26 healthy
      Chinese volunteers under fasted conditions to assess the bioequivalence between two
      formulations of Anastrozole.
Anastrozole is currently used as first-line treatment in locally advanced or metastatic
      breast cancer. A generic anastrozole tablet was developed to offer an alternative to the
      marketed tablet formulation.The aim of the current study was to evaluate the bioequivalence
      between the test and reference formulations of anastrozole in a single-dose, 2-period,
      2-sequence crossover study with a 21-day washout interval. A total of 26 healthy Chinese
      female volunteers were enrolled and completed the study, after oral administration of a
      single dose of 1.0-mg test and reference formulations of anastrozole. Blood samples (3 mL)
      for pharmacokinetic analysis were collected predose and 20min, 40min, 1, 1h20min, 1h40min, 2,
      2h20min, 2h40min, 3, 3.5, 4, 7, 12, 24, 48, and 72 hours postdose and were determined by a
      fully validated high-pressure liquid chromatography-tandem mass spectrometry method. The
      evaluated pharmacokinetic parameters, including Cmax, AUC0-t, AUC0-∞, were assessed for
      bioequivalence based on current guidelines.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the ratios of geometrical mean
time frame: 31 days
description: The two preparations were considered bioequivalent if the 90% CIs of the ratios of the primary pharmacokinetics parameters were within the predefined acceptance range of 80%-125%.
arm group label: test-anastrozole tablet
arm group type: Experimental
description: 1 mg anastrozole was produced and provided by Salutas Pharma GmbH
arm group label: reference-anastrozole tablet
arm group type: Experimental
description: 1 mg anastrozole was produced by AstraZeneca Pharmaceuticals LP.
intervention type: Drug
intervention name: test-anastrozole tablet (Salutas Pharma GmbH)
description: Subjects were allocated to one of two groups randomly and equally with a 21-day washout interval between the two periods.All of them were randomized (1:1) to receive anastrozole as a single oral dose of the test drug or a single 1.0-mg oral dose of Arimidex
arm group label: test-anastrozole tablet
intervention type: Drug
intervention name: reference-anastrozole tablet (Arimidex)
description: Subjects were allocated to one of two groups randomly and equally with a 21-day washout interval between the two periods.All of them were randomized (1:1) to receive anastrozole as a single oral dose of the test drug or a single 1.0-mg oral dose of Arimidex
arm group label: reference-anastrozole tablet
other name: Arimidex
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: yu Cao, doctor
role: Principal Investigator
affiliation: the study director of phase I clinical research center
last name: yu Cao, doctor
phone: 86 18661809090
email: caoyu1767@126.com
last name: ye Tao, master
phone: 86 17853287551
email: taoye165298765@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor
mesh term: Anastrozole
sharing ipd: No