<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/NCT04414254</url>
  </required_header>
  <id_info>
    <org_study_id>QL-YK1-036-001</org_study_id>
    <nct_id>NCT04414254</nct_id>
  </id_info>
  <brief_title>Bioequivalence of Cefprozil Granule in Healthy Chinese Volunteers</brief_title>
  <official_title>Bioequivalence of Cefprozil for Suspension and Granule Formulation in Healthy Chinese Volunteers: Two Single-Dose Crossover Studies</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, single-dose, two-period, two-group, crossover study was conducted&#xD;
      in 60 healthy Chinese volunteers under fasted or fed conditions (30 volunteers for each&#xD;
      condition) to assess the bioequivalence between two formulations of cefprozil.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cefprozil, an oral second-generation semi-synthetic cephalosporin, possesses a broad spectrum&#xD;
      of antimicrobial activity. A granule formulation has been developed to improve medication&#xD;
      adherence of the patients. This study was conducted to assess the bioequivalence of the&#xD;
      granule formulation to dry suspension in healthy Chinese volunteers and estimate the&#xD;
      pharmacokinetics profiles of cefprozil. An open-label, randomized, single-dose, two-period,&#xD;
      two-group, crossover study was conducted in 60 healthy Chinese volunteers under fasted or fed&#xD;
      conditions (30 volunteers for each condition) to assess the bioequivalence between two&#xD;
      formulations of cefprozil. Blood samples were collected at specified time intervals, and the&#xD;
      plasma concentrations of cis- and trans-cefprozil were determined by a validated liquid&#xD;
      chromatography- mass spectrum/ mass spectrum method. Pharmacokinetic and bioavailability&#xD;
      parameters were estimated via non-compartmental methods. Adverse events were also recorded.&#xD;
      If the 90% confidence intervals of the ratios of geometrical mean of test and reference&#xD;
      formulations for Cmax, AUC0-t and AUC0-infer are all within the predefined bioequivalence&#xD;
      criteria range of 80%-125% for cis-, trans-and total cefprozil, the two formulations can be&#xD;
      considered bioequivalent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 11, 2018</start_date>
  <completion_date type="Actual">January 30, 2019</completion_date>
  <primary_completion_date type="Actual">November 22, 2018</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>An open-label, randomized, single-dose, two-period, two-group, crossover study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the ratios of geometrical mean</measure>
    <time_frame>71 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>
  <secondary_outcome>
    <measure>the occurrence rate of adverse events</measure>
    <time_frame>71 Days</time_frame>
    <description>Adverse events were recorded to evaluate the safety of the studied drugs.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>conference-Cefprozil for Suspension®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>&quot;Cefprozil for Suspension®&quot; (125mg/5ml, 50ml/bottle, batch no. F701087, manufactured by Lupin Pharmaceuticals, Inc.)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>test-cefprozil granule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cefprozil granule (125mg, batch no. 8G001F07, manufactured by Qilu Pharmaceutical Co., Ltd)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cefprozil 125mg/5ml Susp; Cefprozil granule (125mg)</intervention_name>
    <description>Subjects were allocated to one of two groups randomly and equally with a 3-day washout interval between the two periods.&quot;Cefprozil for Suspension®&quot; (125mg/5mL, 50mL/bottle, batch no. F701087, manufactured by Lupin Pharmaceuticals, Inc.) and cefprozil granule (125mg, batch no. 8G001F07, manufactured by Qilu Pharmaceutical Co., Ltd) were used in this study.</description>
    <arm_group_label>conference-Cefprozil for Suspension®</arm_group_label>
    <arm_group_label>test-cefprozil granule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female aged between 18 and 55 years old (including the critical&#xD;
             value).&#xD;
&#xD;
          -  The body mass index is in the range of 19-28 kg/m2 (including the critical value). The&#xD;
             weight of male is not less than 50 kg, and that of female is not less than 45 kg&#xD;
             (including the critical value).&#xD;
&#xD;
          -  Subjects who had not any medical history of cardiovascular, digestive, respiratory,&#xD;
             nervous, haemal diseases or hepatic/renal impairment.The following examination show&#xD;
             that the indicators are normal or abnormal without clinical significance. The&#xD;
             examination including: physical examination, 12-lead ECG, vital sign measurements, and&#xD;
             laboratory safety tests .&#xD;
&#xD;
          -  The subjects have no family planning within 6 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;
          -  The subjects could complete the study accorrding to the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any history of hypersensitivity, needlesickness or idiosyncratic reactions to any food&#xD;
             or drug, especially for penicillins or cephalosporins;&#xD;
&#xD;
          -  hepatitis (including hepatitis B and C), positive screening results for AIDS or&#xD;
             syphilis;&#xD;
&#xD;
          -  any history of acute or chronic illness that might affect drug absorption, and/or&#xD;
             metabolism;&#xD;
&#xD;
          -  positive results for urine drug screening;&#xD;
&#xD;
          -  any history of drug abuse in the past 5 years or drug use 3 months prior to screening;&#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;
&#xD;
          -  blood donation, massive blood loss (&gt;400mL) or enrolled in other clinical trials 3&#xD;
             months prior to screening;&#xD;
&#xD;
          -  any use of other prescription drugs (including contraceptive) 14 days prior to&#xD;
             medication for this study;&#xD;
&#xD;
          -  any use of prescription or over-the-counter drugs, functional vitamin, herbal/ alcohol&#xD;
             products, grapefruit-containing or caffeine/xanthine-rich foodand beverages 48 h prior&#xD;
             to medication for this study;&#xD;
&#xD;
          -  the outcome of breath alcohol test &gt; 0mg /mL;&#xD;
&#xD;
          -  dysphagia or having special dietary requirements;&#xD;
&#xD;
          -  occurring acute disease in the screening period or before the medication;&#xD;
&#xD;
          -  lactating or pregnant women;&#xD;
&#xD;
          -  investigator-determined ineligibility.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 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>June 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 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>Cefprozil</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All the technical achievements and outcomes of this trial are owned by Qilu Pharmaceutical Co., Ltd. and the research center. The research center can not publish any academic papers without the consent of the sponsor.</ipd_description>
  </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/NCT04414254
org study id: QL-YK1-036-001
nct id: NCT04414254
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
An open-label, randomized, single-dose, two-period, two-group, crossover study was conducted
      in 60 healthy Chinese volunteers under fasted or fed conditions (30 volunteers for each
      condition) to assess the bioequivalence between two formulations of cefprozil.
Cefprozil, an oral second-generation semi-synthetic cephalosporin, possesses a broad spectrum
      of antimicrobial activity. A granule formulation has been developed to improve medication
      adherence of the patients. This study was conducted to assess the bioequivalence of the
      granule formulation to dry suspension in healthy Chinese volunteers and estimate the
      pharmacokinetics profiles of cefprozil. An open-label, randomized, single-dose, two-period,
      two-group, crossover study was conducted in 60 healthy Chinese volunteers under fasted or fed
      conditions (30 volunteers for each condition) to assess the bioequivalence between two
      formulations of cefprozil. Blood samples were collected at specified time intervals, and the
      plasma concentrations of cis- and trans-cefprozil were determined by a validated liquid
      chromatography- mass spectrum/ mass spectrum method. Pharmacokinetic and bioavailability
      parameters were estimated via non-compartmental methods. Adverse events were also recorded.
      If the 90% confidence intervals of the ratios of geometrical mean of test and reference
      formulations for Cmax, AUC0-t and AUC0-infer are all within the predefined bioequivalence
      criteria range of 80%-125% for cis-, trans-and total cefprozil, the two formulations can be
      considered bioequivalent.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: An open-label, randomized, single-dose, two-period, two-group, crossover study.
primary purpose: Treatment
masking: None (Open Label)
measure: the ratios of geometrical mean
time frame: 71 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%.
measure: the occurrence rate of adverse events
time frame: 71 Days
description: Adverse events were recorded to evaluate the safety of the studied drugs.
arm group label: conference-Cefprozil for Suspension®
arm group type: Experimental
description: "Cefprozil for Suspension®" (125mg/5ml, 50ml/bottle, batch no. F701087, manufactured by Lupin Pharmaceuticals, Inc.)
arm group label: test-cefprozil granule
arm group type: Experimental
description: cefprozil granule (125mg, batch no. 8G001F07, manufactured by Qilu Pharmaceutical Co., Ltd)
intervention type: Drug
intervention name: Cefprozil 125mg/5ml Susp; Cefprozil granule (125mg)
description: Subjects were allocated to one of two groups randomly and equally with a 3-day washout interval between the two periods."Cefprozil for Suspension®" (125mg/5mL, 50mL/bottle, batch no. F701087, manufactured by Lupin Pharmaceuticals, Inc.) and cefprozil granule (125mg, batch no. 8G001F07, manufactured by Qilu Pharmaceutical Co., Ltd) were used in this study.
arm group label: conference-Cefprozil for Suspension®
arm group label: test-cefprozil granule
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 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: Cefprozil
sharing ipd: No
ipd description: All the technical achievements and outcomes of this trial are owned by Qilu Pharmaceutical Co., Ltd. and the research center. The research center can not publish any academic papers without the consent of the sponsor.