<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/NCT03826641</url>
  </required_header>
  <id_info>
    <org_study_id>HM-DAME-101</org_study_id>
    <nct_id>NCT03826641</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1801 in Healthy Subjects</brief_title>
  <official_title>An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1801 in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hanmi Pharmaceutical Company Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hanmi Pharmaceutical Company Limited</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>
      An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics,&#xD;
      safety and tolerability of HCP1801 in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">April 16, 2019</completion_date>
  <primary_completion_date type="Actual">March 25, 2019</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>Cmax of Dapagliflozin</measure>
    <time_frame>pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour</time_frame>
    <description>pharmacokinetic evaluation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUClast of Dapagliflozin</measure>
    <time_frame>pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour</time_frame>
    <description>pharmacokinetic evaluation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Metformin</measure>
    <time_frame>pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour</time_frame>
    <description>pharmacokinetic evaluation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUClast of Metformin</measure>
    <time_frame>pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour</time_frame>
    <description>pharmacokinetic evaluation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUCinf of Dapagliflozin</measure>
    <time_frame>pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour</time_frame>
    <description>pharmacokinetic evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax of Dapagliflozin</measure>
    <time_frame>pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour</time_frame>
    <description>pharmacokinetic evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 of Dapagliflozin</measure>
    <time_frame>pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour</time_frame>
    <description>pharmacokinetic evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F of Dapagliflozin</measure>
    <time_frame>pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour</time_frame>
    <description>pharmacokinetic evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vd/F of Dapagliflozin</measure>
    <time_frame>pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour</time_frame>
    <description>pharmacokinetic evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCinf of Metformin</measure>
    <time_frame>pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour</time_frame>
    <description>pharmacokinetic evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax of Metformin</measure>
    <time_frame>pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour</time_frame>
    <description>pharmacokinetic evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 of Metformin</measure>
    <time_frame>pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour</time_frame>
    <description>pharmacokinetic evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F of Metformin</measure>
    <time_frame>pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour</time_frame>
    <description>pharmacokinetic evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vd/F of Metformin</measure>
    <time_frame>pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour</time_frame>
    <description>pharmacokinetic evaluation</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1 : Fasted state + HCP1805, Period 2 : Fasted state + HCP1801</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1 : Fasted state + HCP1801, Period 2 : Fasted state + HCP1805</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1 : High fat diet + HCP1805, Period 2 : High fat diet + HCP1801</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1 : High fat diet + HCP1801, Period 2 : High fat diet + HCP1805</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HCP1805</intervention_name>
    <description>Dapagliflozin/Metformin (Xigduo XR) 10/1000mg</description>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_label>Sequence 3</arm_group_label>
    <arm_group_label>Sequence 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HCP1801</intervention_name>
    <description>Dapagliflozin/Metformin 10/1000mg</description>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_label>Sequence 3</arm_group_label>
    <arm_group_label>Sequence 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 19~45 years in healthy volunteers&#xD;
&#xD;
          2. BMI is more than 18.5 kg/m^2 , no more than 29.9 kg/m^2&#xD;
&#xD;
          3. Subjects who have ability to comprehend the objectives, contents of study and property&#xD;
             of study drug before participating in trial and have willingness to sign of informed&#xD;
             consent in writing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of medical history or a concurrent disease that may interfere with treatment&#xD;
             and safety assessment or completion of this clinical study, including clinically&#xD;
             significant disorders in digestive system, neuropsychiatric system, endocrine system,&#xD;
             liver, cardiovascular system&#xD;
&#xD;
          2. Subjects who judged ineligible by the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kyungpook National University Hospital</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>July 12, 2022</last_update_submitted>
  <last_update_submitted_qc>July 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03826641
org study id: HM-DAME-101
nct id: NCT03826641
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics,
      safety and tolerability of HCP1801 in healthy subjects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax of Dapagliflozin
time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
description: pharmacokinetic evaluation
measure: AUClast of Dapagliflozin
time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
description: pharmacokinetic evaluation
measure: Cmax of Metformin
time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
description: pharmacokinetic evaluation
measure: AUClast of Metformin
time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
description: pharmacokinetic evaluation
measure: AUCinf of Dapagliflozin
time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
description: pharmacokinetic evaluation
measure: Tmax of Dapagliflozin
time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
description: pharmacokinetic evaluation
measure: t1/2 of Dapagliflozin
time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
description: pharmacokinetic evaluation
measure: CL/F of Dapagliflozin
time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
description: pharmacokinetic evaluation
measure: Vd/F of Dapagliflozin
time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
description: pharmacokinetic evaluation
measure: AUCinf of Metformin
time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
description: pharmacokinetic evaluation
measure: Tmax of Metformin
time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
description: pharmacokinetic evaluation
measure: t1/2 of Metformin
time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
description: pharmacokinetic evaluation
measure: CL/F of Metformin
time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
description: pharmacokinetic evaluation
measure: Vd/F of Metformin
time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
description: pharmacokinetic evaluation
arm group label: Sequence 1
arm group type: Experimental
description: Period 1 : Fasted state + HCP1805, Period 2 : Fasted state + HCP1801
arm group label: Sequence 2
arm group type: Experimental
description: Period 1 : Fasted state + HCP1801, Period 2 : Fasted state + HCP1805
arm group label: Sequence 3
arm group type: Experimental
description: Period 1 : High fat diet + HCP1805, Period 2 : High fat diet + HCP1801
arm group label: Sequence 4
arm group type: Experimental
description: Period 1 : High fat diet + HCP1801, Period 2 : High fat diet + HCP1805
intervention type: Drug
intervention name: HCP1805
description: Dapagliflozin/Metformin (Xigduo XR) 10/1000mg
arm group label: Sequence 1
arm group label: Sequence 2
arm group label: Sequence 3
arm group label: Sequence 4
intervention type: Drug
intervention name: HCP1801
description: Dapagliflozin/Metformin 10/1000mg
arm group label: Sequence 1
arm group label: Sequence 2
arm group label: Sequence 3
arm group label: Sequence 4
criteria: 
gender: All
minimum age: 19 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Sponsor
sharing ipd: No