<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/NCT03232710</url>
  </required_header>
  <id_info>
    <org_study_id>KH716-E01-CRP-1.1</org_study_id>
    <nct_id>NCT03232710</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study of Bosiqing and ABILIFY Under Fasting/Fed Condition</brief_title>
  <official_title>A Single-dose, Two-treatment, Two-sequence, Two-period, Two Way Crossover Bioequivalence Study of Bosiqing Aripiprazole Orally Disintegrating Tablets and ABILIFY Under Fasting/Fed Condition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chengdu Kanghong Pharmaceutical Group Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chengdu Kanghong Pharmaceutical Group Co., Ltd.</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>
      To compare the rate and extent of absorption of Aripiprazole Orally disintegrating tablets 10&#xD;
      mg of Chengdu Kanghong Pharmaceutical Group Co.,Ltd, China and ABILIFY (Aripiprazole) 10 mg&#xD;
      orodispersible tablets of Otsuka Pharmaceutical Europe Ltd. in healthy, adult, human subjects&#xD;
      under fasting/fed condition as well as to monitor the safety and tolerability of subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 26, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">April 30, 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetic parameter: Cmax</measure>
    <time_frame>day 54</time_frame>
    <description>Bioequivalence based on Peak Plasma Concentration (Cmax) under fasting and fed condition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameter: AUC</measure>
    <time_frame>day 54</time_frame>
    <description>Bioequivalence based on Area under the plasma concentration versus time curves (AUC) under fasting and fed condition</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>up to day 54</time_frame>
    <description>To observe the type, incidence and severity of adverse events in the study.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">66</enrollment>
  <condition>Bioequivalence</condition>
  <arm_group>
    <arm_group_label>pilot study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>group 1 (under fasting condition)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>group 2 (under fasting condition)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>group 3 (under fed condition)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>group 4 (under fed condition)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bosiqing</intervention_name>
    <description>Aripiprazole Orally disintegrating tablets 10mg</description>
    <arm_group_label>group 1 (under fasting condition)</arm_group_label>
    <arm_group_label>group 2 (under fasting condition)</arm_group_label>
    <arm_group_label>group 3 (under fed condition)</arm_group_label>
    <arm_group_label>group 4 (under fed condition)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>abilify</intervention_name>
    <description>Aripiprazol orodispersible tablets 10mg</description>
    <arm_group_label>group 1 (under fasting condition)</arm_group_label>
    <arm_group_label>group 2 (under fasting condition)</arm_group_label>
    <arm_group_label>group 3 (under fed condition)</arm_group_label>
    <arm_group_label>group 4 (under fed condition)</arm_group_label>
    <arm_group_label>pilot study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects willing to adhere to the protocol requirements and to provide written&#xD;
             informed consent.&#xD;
&#xD;
          2. Subjects aged between 45 and 65 years，healthy male and non-pregnant, non breast&#xD;
             feeding female.&#xD;
&#xD;
          3. Subjects' weight within clinically acceptable normal range according to normal values&#xD;
             for Body Mass Index (19.00 to 26.00 kg/m2) with minimum of 50 kg weight for male, and&#xD;
             minimum of 45 kg weight for female.&#xD;
&#xD;
          4. No medical history of significant cardiovascular, pulmonary, hepatic, renal,&#xD;
             gastrointestinal, endocrine, immunological, dermatological, neurological, urogenital&#xD;
             or psychiatric disease or disorder.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1)Subjects with family history of muscular dystonia or the subject has had the drug&#xD;
             source dystonia.&#xD;
&#xD;
             2）Subject with history of a asthma. 3）Subject with any (acute or chronic) history of&#xD;
             mental illness or have family history of mental illness.&#xD;
&#xD;
             4）Subject have alzheimer's or alzheimer's disease. 5）Subject was hospitalized within&#xD;
             60 days prior to the first dose of the study drug 6）Subject smoking more than five&#xD;
             cigarettes within 1 month prior to the first dose study drug.&#xD;
&#xD;
             7）History or presence of significant easy bruising or bleeding 8）History or presence&#xD;
             of drug abuse. 9）History of allergic reactions. 10）History or presence of taking&#xD;
             psychotropic drugs。 11）Subjects having positive urine screen for drugs of abuse&#xD;
             including Methamphetamine, MDMA, ketamine, morphine, heroin.&#xD;
&#xD;
             12）Any treatment which could bring about induction or inhibition of hepatic microsomal&#xD;
             enzyme system within 3 weeks prior to Period 01 dosing.&#xD;
&#xD;
             13）Consumption of hypericum perforatum containing products and grapefruit or&#xD;
             grapefruit juice from 72 hours prior admission to 3 days after trail end.&#xD;
&#xD;
             14）Subject involved other clinical trials of drugs within 3 months prior to period 01&#xD;
             dosing.&#xD;
&#xD;
             15）Subject with abnormal laboratory tests and diagnosed by physicians as clinically&#xD;
             significant 17）Abnormal vital signs test for any one or more:&#xD;
&#xD;
        Abnormal blood pressure:&#xD;
&#xD;
          -  Systolic pressure is lower than 80mmHg and/or diastolic pressure down to 40mmHg in&#xD;
             sitting position.&#xD;
&#xD;
          -  Systolic pressure is higher than 140mmHg and/or diastolic pressure higher than 90mmHg&#xD;
             in sitting position.&#xD;
&#xD;
        Abnormal cardiac rate:&#xD;
&#xD;
          -  cardiac rate lower than 50&#xD;
&#xD;
          -  cardiac rate higher than 50 18）Blood alcohol test values≥10mg/dL 19）Volunteer who have&#xD;
             donated blood components within 2 weeks prior to the first dose or donated blood (more&#xD;
             than 200 ml within 4 weeks; more than 400 ml within 60 days) prior to the first dose;&#xD;
             Volunteer who plan to donate blood during the study or 4 weeks after study; Volunteer&#xD;
             who lost blood (more than 50ml within 7days or more than 400ml within 30 days) for&#xD;
             surgery.&#xD;
&#xD;
             20）Subjects not willing to follow approved birth control methods for the duration of&#xD;
             the study 21）ubjects having positive Serum β-hCG test. 22）Subjects plan to donate&#xD;
             sperm during study period or 30 days after study 23）Hamilton depression Rating Scale (&#xD;
             17 ) score above 7 points. 24）History of blood phobia. Subjects whom the investigator&#xD;
             deems necessary to exclude.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Xiang Jin</last_name>
    <phone>+83-13880932568</phone>
    <email>11679295@qq.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>West China Hospital of Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiang Jin</last_name>
      <email>11679295@qq.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>July 27, 2017</last_update_submitted>
  <last_update_submitted_qc>July 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2017</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>Aripiprazole</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/NCT03232710
org study id: KH716-E01-CRP-1.1
nct id: NCT03232710
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To compare the rate and extent of absorption of Aripiprazole Orally disintegrating tablets 10
      mg of Chengdu Kanghong Pharmaceutical Group Co.,Ltd, China and ABILIFY (Aripiprazole) 10 mg
      orodispersible tablets of Otsuka Pharmaceutical Europe Ltd. in healthy, adult, human subjects
      under fasting/fed condition as well as to monitor the safety and tolerability of subjects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Pharmacokinetic parameter: Cmax
time frame: day 54
description: Bioequivalence based on Peak Plasma Concentration (Cmax) under fasting and fed condition
measure: Pharmacokinetic parameter: AUC
time frame: day 54
description: Bioequivalence based on Area under the plasma concentration versus time curves (AUC) under fasting and fed condition
measure: Adverse Events
time frame: up to day 54
description: To observe the type, incidence and severity of adverse events in the study.
arm group label: pilot study group
arm group type: Experimental
arm group label: group 1 (under fasting condition)
arm group type: Experimental
arm group label: group 2 (under fasting condition)
arm group type: Experimental
arm group label: group 3 (under fed condition)
arm group type: Experimental
arm group label: group 4 (under fed condition)
arm group type: Experimental
intervention type: Drug
intervention name: Bosiqing
description: Aripiprazole Orally disintegrating tablets 10mg
arm group label: group 1 (under fasting condition)
arm group label: group 2 (under fasting condition)
arm group label: group 3 (under fed condition)
arm group label: group 4 (under fed condition)
intervention type: Drug
intervention name: abilify
description: Aripiprazol orodispersible tablets 10mg
arm group label: group 1 (under fasting condition)
arm group label: group 2 (under fasting condition)
arm group label: group 3 (under fed condition)
arm group label: group 4 (under fed condition)
arm group label: pilot study group
criteria: 
gender: All
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Xiang Jin
phone: +83-13880932568
email: 11679295@qq.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Aripiprazole