<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/NCT02974439</url>
  </required_header>
  <id_info>
    <org_study_id>HN-LD</org_study_id>
    <nct_id>NCT02974439</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study of Amlodipine and Norvasc Under Fasting and FED Conditions in Chinese Healthy Volunteers</brief_title>
  <official_title>An Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study of Amlodipine and Norvasc Under Fasting Condition Sand Under Non-fasting(FED) Conditions in Chinese Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Haini Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Haini Pharmaceutical Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the pharmacokinetics and bioequivalence of Amlodipine Besylate Tablets 5&#xD;
      mg versus Norvasc 5 mg tablets administered as 5 mg tablet in healthy volunteers with a&#xD;
      washout period of 14 days&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence&#xD;
      Study with a washout period of 14 days. During each session, the subjects will be&#xD;
      administered a single dose of 5mg amlodipine (one LANDI-Amlodipine Tablet 5mg or one Norvasc&#xD;
      Tablet 5mg) under fasting and FED conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 23, 2016</start_date>
  <completion_date type="Actual">March 21, 2017</completion_date>
  <primary_completion_date type="Actual">March 21, 2017</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>Bioequivalence based on Peak Plasma Concentration (Cmax)</measure>
    <time_frame>144 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bioequivalence based on Area under the plasma concentration versus time curves (AUC)</measure>
    <time_frame>144 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Bioequivalence</condition>
  <arm_group>
    <arm_group_label>LANDI-Amlodipine Besylate Tablet 5mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the study session, healthy subjects will be administered a single dose of LANDI-AmlodipineTablet 5mg under fasting and FED conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Norvasc Tablets 5mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>During the study session, healthy subjects will be administered a single dose of Norvasc Tablets 5mg under fasting and FED conditions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LANDI-Amlodipine Besylate Tablet 5mg</intervention_name>
    <description>LANDI-Amlodipine Besylate Tablet 5mg is a generic product manufactured by YangTZE River Pharmaceutical Group Shanghai Haini Pharmaceutical Co., Ltd.</description>
    <arm_group_label>LANDI-Amlodipine Besylate Tablet 5mg</arm_group_label>
    <other_name>Amlodipine Tablet 5mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Norvasc Tablets 5mg</intervention_name>
    <description>Norvasc Tablet 5mg will be used as a comparator drug for the BE study.</description>
    <arm_group_label>Norvasc Tablets 5mg</arm_group_label>
    <other_name>Amlodipine Tablet 5mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy adult volunteers of 18-40 years old, male or female.&#xD;
&#xD;
          2. Body mass index (BMI) ranges from 19.0 to 25.0 kg/m2, body weight ≥ 50 kg for male and&#xD;
             45 kg for female.&#xD;
&#xD;
          3. No history of heart, liver, kidney, gastrointestinal tract diseases, nervous system,&#xD;
             neural abnormities or metabolic abnormalities; No preparation allergies, serious&#xD;
             infection or injury, etc.&#xD;
&#xD;
          4. Medically healthy subjects with clinically normal laboratory profiles and ECGs.&#xD;
&#xD;
          5. Subjects must agree to take effective contraceptive methods to prevent pregnancy from&#xD;
             the start of screening until 3 months of last dose administration&#xD;
&#xD;
          6. Subjects are fully informed and voluntarily consent to participate in this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of allergy or hypersensitivity to amlodipine&#xD;
&#xD;
          2. Significant history of neurological, cardiovascular, digestive, respiratory, urinary,&#xD;
             hematological, dysmetabolism or other diseases (such as psychosis) which is&#xD;
             unfavorable to the study&#xD;
&#xD;
          3. History of postural hypotension&#xD;
&#xD;
          4. Blood donation or lost more than 400mL blood within 3 months prior to the study&#xD;
&#xD;
          5. Use of medications within 2 weeks before the study&#xD;
&#xD;
          6. Volunteer in any other clinical drug study within 3 months prior to this study&#xD;
&#xD;
          7. Drug abuse or alcohol abuse (220ml beer /day or &gt;5 times in 2 hours)&#xD;
&#xD;
          8. Smoker (&gt;10 cigarettes/day)&#xD;
&#xD;
          9. A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV)&#xD;
             antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test&#xD;
&#xD;
         10. Abnormal chest X-ray results with clinical significance&#xD;
&#xD;
         11. Women of childbearing potential, pregnant and lactating women.&#xD;
&#xD;
         12. Other unfavorable factors diagnosed by investigators.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yanmei Liu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Xuhui Central Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Haini Pharmaceutical Co., Ltd.</name>
      <address>
        <city>Shanghai</city>
        <zip>201318</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>October 12, 2017</last_update_submitted>
  <last_update_submitted_qc>October 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 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>Amlodipine</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/NCT02974439
org study id: HN-LD
nct id: NCT02974439
lead sponsor: 
has dmc: Yes
This study evaluates the pharmacokinetics and bioequivalence of Amlodipine Besylate Tablets 5
      mg versus Norvasc 5 mg tablets administered as 5 mg tablet in healthy volunteers with a
      washout period of 14 days
The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence
      Study with a washout period of 14 days. During each session, the subjects will be
      administered a single dose of 5mg amlodipine (one LANDI-Amlodipine Tablet 5mg or one Norvasc
      Tablet 5mg) under fasting and FED conditions.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Bioequivalence based on Peak Plasma Concentration (Cmax)
time frame: 144 hours
measure: Bioequivalence based on Area under the plasma concentration versus time curves (AUC)
time frame: 144 hours
arm group label: LANDI-Amlodipine Besylate Tablet 5mg
arm group type: Experimental
description: During the study session, healthy subjects will be administered a single dose of LANDI-AmlodipineTablet 5mg under fasting and FED conditions.
arm group label: Norvasc Tablets 5mg
arm group type: Active Comparator
description: During the study session, healthy subjects will be administered a single dose of Norvasc Tablets 5mg under fasting and FED conditions.
intervention type: Drug
intervention name: LANDI-Amlodipine Besylate Tablet 5mg
description: LANDI-Amlodipine Besylate Tablet 5mg is a generic product manufactured by YangTZE River Pharmaceutical Group Shanghai Haini Pharmaceutical Co., Ltd.
arm group label: LANDI-Amlodipine Besylate Tablet 5mg
other name: Amlodipine Tablet 5mg
intervention type: Drug
intervention name: Norvasc Tablets 5mg
description: Norvasc Tablet 5mg will be used as a comparator drug for the BE study.
arm group label: Norvasc Tablets 5mg
other name: Amlodipine Tablet 5mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yanmei Liu
role: Principal Investigator
affiliation: Shanghai Xuhui Central Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Amlodipine
sharing ipd: No