<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/NCT03261427</url>
  </required_header>
  <id_info>
    <org_study_id>YJ16-101</org_study_id>
    <nct_id>NCT03261427</nct_id>
  </id_info>
  <brief_title>Evaluate the Pharmacokinetic Characteristics and Safety/Tolerability of YNP-1807 Compared to Lyrica® After Oral Administration Adult Volunteers</brief_title>
  <official_title>A Randomized, Open-label, Phase I Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety/Tolerability of YNP-1807 Compared to Lyrica® After Oral Administration in Healthy Adult Volunteers: Part I- Single Dosing/Part II- Multiple Dosing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yungjin Pharm. Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yungjin Pharm. Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this trial to compare the pharmacokinetic characteristics of&#xD;
      YNP-1807(Pregabalin 330mg) and Lyrica capsule(Pregabalin 150mg). YNP-1807 is made by Yungjin&#xD;
      Pharm. Primary endpoints are AUClast and Cmax and secondary endpoints are AUCinf, Tmax, t1/2,&#xD;
      Vd/f, CL/f.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 14, 2017</start_date>
  <completion_date type="Actual">March 29, 2018</completion_date>
  <primary_completion_date type="Actual">October 11, 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>Part I : AUClast of Pregabalin</measure>
    <time_frame>0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I : Cmax of Pregabalin</measure>
    <time_frame>0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II : AUCτ,ss of Pregabalin</measure>
    <time_frame>Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part II : Cmax,ss of Pregabalin</measure>
    <time_frame>Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part I : AUCinf of Pregabalin</measure>
    <time_frame>0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I : Tmax of Pregabalin</measure>
    <time_frame>0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I : t1/2 of Pregabalin</measure>
    <time_frame>0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I : Vd/F of Pregabalin</measure>
    <time_frame>0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I : CL/F of Pregabalin</measure>
    <time_frame>0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part II : Cmin,ss of Pregabalin</measure>
    <time_frame>Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part II : AUClast,ss of Pregabalin</measure>
    <time_frame>Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part II : Tmax,ss of Pregabalin</measure>
    <time_frame>Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part II : t1/2 of Pregabalin</measure>
    <time_frame>Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part II : CLss/F of Pregabalin</measure>
    <time_frame>Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part II : Vdss/F of Pregabalin</measure>
    <time_frame>Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part II : accumulation ratio(Cmax) of Pregabalin</measure>
    <time_frame>Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part II : accumulation ratio(AUCτ) of Pregabalin</measure>
    <time_frame>Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>YNP-1807 Tablet(Pregabalin 330mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>YNP-1807(Pregabalin 330mg), QD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lyrica Capsule(Pregabalin 150mg)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lyrica Capsule(Pregabalin 150mg), BID</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lyrica 150Mg Capsule</intervention_name>
    <description>150 mg oral administered (BID)</description>
    <arm_group_label>Lyrica Capsule(Pregabalin 150mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>YNP-1807 330Mg Tablet</intervention_name>
    <description>330 mg oral administered (QD)</description>
    <arm_group_label>YNP-1807 Tablet(Pregabalin 330mg)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  19 years to 55 years healthy volunteers adult at screening visit&#xD;
&#xD;
          -  For male, weight is more than 55 kg, for female, weight is more than 50 kg.&#xD;
&#xD;
          -  Body mass index(BMI) value : 18.5 to 25.0 kg/m2&#xD;
&#xD;
          -  If female, should be included one at least as following&#xD;
&#xD;
               -  menopausal(menstruation for 2 years minimum)&#xD;
&#xD;
               -  surgery infertility&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any history of drug overdose or dependence&#xD;
&#xD;
          -  Female who is pregnant or nursing&#xD;
&#xD;
          -  AST, ALT &gt; ULN*1.25&#xD;
&#xD;
          -  Total bilirubin &gt; ULN*1.5&#xD;
&#xD;
          -  CPK &gt; ULN*1.5&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MinSoo Park, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Severance Hospital, Seoul, Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Yonsei-ro Seodaemun-gu</state>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>July 8, 2019</last_update_submitted>
  <last_update_submitted_qc>July 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2019</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>Pregabalin</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/NCT03261427
org study id: YJ16-101
nct id: NCT03261427
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this trial to compare the pharmacokinetic characteristics of
      YNP-1807(Pregabalin 330mg) and Lyrica capsule(Pregabalin 150mg). YNP-1807 is made by Yungjin
      Pharm. Primary endpoints are AUClast and Cmax and secondary endpoints are AUCinf, Tmax, t1/2,
      Vd/f, CL/f.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Part I : AUClast of Pregabalin
time frame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part I : Cmax of Pregabalin
time frame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part II : AUCτ,ss of Pregabalin
time frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part II : Cmax,ss of Pregabalin
time frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part I : AUCinf of Pregabalin
time frame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part I : Tmax of Pregabalin
time frame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part I : t1/2 of Pregabalin
time frame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part I : Vd/F of Pregabalin
time frame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part I : CL/F of Pregabalin
time frame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part II : Cmin,ss of Pregabalin
time frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part II : AUClast,ss of Pregabalin
time frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part II : Tmax,ss of Pregabalin
time frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part II : t1/2 of Pregabalin
time frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part II : CLss/F of Pregabalin
time frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part II : Vdss/F of Pregabalin
time frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part II : accumulation ratio(Cmax) of Pregabalin
time frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part II : accumulation ratio(AUCτ) of Pregabalin
time frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
arm group label: YNP-1807 Tablet(Pregabalin 330mg)
arm group type: Experimental
description: YNP-1807(Pregabalin 330mg), QD
arm group label: Lyrica Capsule(Pregabalin 150mg)
arm group type: Active Comparator
description: Lyrica Capsule(Pregabalin 150mg), BID
intervention type: Drug
intervention name: Lyrica 150Mg Capsule
description: 150 mg oral administered (BID)
arm group label: Lyrica Capsule(Pregabalin 150mg)
intervention type: Drug
intervention name: YNP-1807 330Mg Tablet
description: 330 mg oral administered (QD)
arm group label: YNP-1807 Tablet(Pregabalin 330mg)
criteria: 
gender: All
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: MinSoo Park, MD,PhD
role: Principal Investigator
affiliation: Severance Hospital, Seoul, Korea
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Pregabalin