<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/NCT04465266</url>
  </required_header>
  <id_info>
    <org_study_id>CLN-110</org_study_id>
    <nct_id>NCT04465266</nct_id>
  </id_info>
  <brief_title>A Phase 1 PK Study of Tolperisone in Healthy Subjects</brief_title>
  <official_title>A Phase 1 Crossover Study of Single and Multiple Dose Pharmacokinetics, and Dose Linearity, of Tolperisone in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neurana Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Neurana Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, single-blind, single and multiple dose crossover subjects in healthy&#xD;
      adult subjects&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-center, in-patient, treatment sequence-randomized, single-blind SD and MD&#xD;
      crossover study in 27 healthy adult male and female subjects. Subjects will be admitted to&#xD;
      the clinic on Day-1 and discharged the morning of Day 5 of each treatment period. Subjects&#xD;
      will be on a standard diet during each inpatient treatment period; study drug will be&#xD;
      administered in the fasted state for PK assessments on Days 1 and 4 of each treatment period.&#xD;
      Subjects will have a follow-up phone call 7 to 10 days after the last dose in Period 3. There&#xD;
      will be a 6 to 8 day washout between the last dose in Period 1 and the first dose in Period&#xD;
      2, and between the last dose in Period 2 and the first dose in Period 3.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 28, 2020</start_date>
  <completion_date type="Actual">September 1, 2021</completion_date>
  <primary_completion_date type="Actual">August 21, 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>
    <intervention_model_description>sequence randomized</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>taken over 4 days per dose</time_frame>
    <description>Maximum plasma concentration of tolperisone</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax</measure>
    <time_frame>taken over 4 days per dose</time_frame>
    <description>Time of maximum plasma concentration of tolperisone</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC</measure>
    <time_frame>taken over 4 days per dose</time_frame>
    <description>Area under the curve of tolperisone plasma concentrations</description>
  </primary_outcome>
  <primary_outcome>
    <measure>T1/2</measure>
    <time_frame>taken over 4 days per dose</time_frame>
    <description>Half life of tolperisone</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>50 mg Tolperisone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 mg tablets (2 days SD, 2 days TID)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>100 mg of Tolperisone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100 mg tablets (2 days SD, 2 days TID)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>200 mg Tolperisone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>200 mg tablets (2 days SD, 2 days TID)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tolperisone</intervention_name>
    <description>tablets</description>
    <arm_group_label>100 mg of Tolperisone</arm_group_label>
    <arm_group_label>200 mg Tolperisone</arm_group_label>
    <arm_group_label>50 mg Tolperisone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Generally Healthy Subjects&#xD;
&#xD;
          -  BMI between 18.5 and 32.5 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - pregnant or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Worldwide Clinical Trials Early Phase Services, LLC</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>January 28, 2022</last_update_submitted>
  <last_update_submitted_qc>January 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2022</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>Tolperisone</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/NCT04465266
org study id: CLN-110
nct id: NCT04465266
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, single-blind, single and multiple dose crossover subjects in healthy
      adult subjects
This is a single-center, in-patient, treatment sequence-randomized, single-blind SD and MD
      crossover study in 27 healthy adult male and female subjects. Subjects will be admitted to
      the clinic on Day-1 and discharged the morning of Day 5 of each treatment period. Subjects
      will be on a standard diet during each inpatient treatment period; study drug will be
      administered in the fasted state for PK assessments on Days 1 and 4 of each treatment period.
      Subjects will have a follow-up phone call 7 to 10 days after the last dose in Period 3. There
      will be a 6 to 8 day washout between the last dose in Period 1 and the first dose in Period
      2, and between the last dose in Period 2 and the first dose in Period 3.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: sequence randomized
primary purpose: Other
masking: Single (Participant)
measure: Cmax
time frame: taken over 4 days per dose
description: Maximum plasma concentration of tolperisone
measure: Tmax
time frame: taken over 4 days per dose
description: Time of maximum plasma concentration of tolperisone
measure: AUC
time frame: taken over 4 days per dose
description: Area under the curve of tolperisone plasma concentrations
measure: T1/2
time frame: taken over 4 days per dose
description: Half life of tolperisone
arm group label: 50 mg Tolperisone
arm group type: Experimental
description: 50 mg tablets (2 days SD, 2 days TID)
arm group label: 100 mg of Tolperisone
arm group type: Experimental
description: 100 mg tablets (2 days SD, 2 days TID)
arm group label: 200 mg Tolperisone
arm group type: Experimental
description: 200 mg tablets (2 days SD, 2 days TID)
intervention type: Drug
intervention name: Tolperisone
description: tablets
arm group label: 100 mg of Tolperisone
arm group label: 200 mg Tolperisone
arm group label: 50 mg Tolperisone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tolperisone