<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/NCT02988024</url>
  </required_header>
  <id_info>
    <org_study_id>LY03005/CT-USA-103</org_study_id>
    <nct_id>NCT02988024</nct_id>
  </id_info>
  <brief_title>Pilot BA Study of New LY03005 vs Pristiq</brief_title>
  <official_title>A Randomized, Open-Label, Single-Dose Study to Assess the Relative Bioavailability of LY03005 Oral Tablets Versus Pristiq Oral Tablets Under Fasting Conditions in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Luye Pharma Group Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Luye Pharma Group Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objects of this study is to assess the relative bioavailability (BA) of 80 mg LY03005&#xD;
      oral tablets compared to 50 mg Pristiq® oral tablets after a single oral intake under fasting&#xD;
      conditions in healthy subjects between 18 and 50 years of age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twenty (20) eligible subjects will be enrolled and assigned to either LY03005 group or&#xD;
      Pristiq group at a 1:1 ratio at one site in the USA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 7, 2016</start_date>
  <completion_date type="Actual">December 28, 2016</completion_date>
  <primary_completion_date type="Actual">December 28, 2016</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under curve (AUC) for the Pharmacokinetics (PK) of LY03005</measure>
    <time_frame>4 days</time_frame>
    <description>PK Samples drawn at 0 (within 30 minutes prior to dosing), 1,2,3,4 (+/- 5 min), 6,8,10,12,23,32,48 and 72 hours (+/- 15 min) after dosing.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Major Depression</condition>
  <arm_group>
    <arm_group_label>LY03005</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LY03005 80 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pristiq</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pristiq 50 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY03005</intervention_name>
    <description>LY03005</description>
    <arm_group_label>LY03005</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pristiq</intervention_name>
    <arm_group_label>Pristiq</arm_group_label>
    <other_name>Desvenlafaxine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Are capable of giving informed consent and complying with study procedures;&#xD;
&#xD;
          2. Male and female subjects between the ages of 18 and 50 years;&#xD;
&#xD;
          3. Considered healthy by the Principal Investigator, based on a detailed medical history,&#xD;
             full physical examination, clinical laboratory tests, 12-lead ECG and vital signs;&#xD;
&#xD;
          4. Nonsmoker, defined as not having smoked or used any form of tobacco in more than 6&#xD;
             months before screening based on subject report;&#xD;
&#xD;
          5. Body mass index (BMI) of 19 to 30 kg/m 2 inclusive and body weight not less than 50&#xD;
             kg;&#xD;
&#xD;
          6. Willing and able to adhere to study restrictions and to be confined at the clinical&#xD;
             research center.&#xD;
&#xD;
          7. All female subjects no matter of age must have a negative pregnancy test result at&#xD;
             screening. In addition, female subjects must meet one of the following three&#xD;
             conditions: (i) postmenopausal for at least 2 years, (ii) surgically sterile based on&#xD;
             subject report, or (iii) if child-bearing potential, practicing or agree to practice&#xD;
             an effective method of birth control by using an acceptable method of contraception.&#xD;
&#xD;
        Acceptable methods of birth control include oral, injected, vaginal or patch contraceptive,&#xD;
        IUD (Intrauterine device)(copper intrauterine device), or double- barrier method (e.g.,&#xD;
        condom, diaphragm or cervical cap with spermicidal foam, cream, gel or suppository).&#xD;
        Acceptable methods of birth control must be used for at least 14 days prior to the use of&#xD;
        study drug, during the study and within one month after the end of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Clinically significant past history of gastrointestinal, cardiovascular,&#xD;
             musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic,&#xD;
             bronchopulmonary, neurologic, immunologic, lipid metabolism disorders,&#xD;
             ophthalmological, or drug hypersensitivity;&#xD;
&#xD;
          2. History of suicide attempt in the past 12 months and/or seen by the investigators&#xD;
             having a significant history of risk of suicide or homicide;&#xD;
&#xD;
          3. History or presence of malignancy other than adequately treated basal cell skin&#xD;
             cancer;&#xD;
&#xD;
          4. Clinically relevant illness within one month prior to the screening visit or at&#xD;
             screening visit that may interfere with the conduct of this study;&#xD;
&#xD;
          5. Subjects with a mean systolic blood pressure of three measurements &gt;140 mmHg, or a&#xD;
             mean diastolic blood pressure of three measurements &gt;90 mmHg at screening;&#xD;
&#xD;
          6. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface&#xD;
             antigen (HBsAg), or hepatitis C antibody;&#xD;
&#xD;
          7. A history of seizure. However, a history of febrile seizure is allowed;&#xD;
&#xD;
          8. A hospital admission or major surgery within 30 days prior to screening;&#xD;
&#xD;
          9. Participation in any other investigational drug trial within 30 days prior to&#xD;
             screening;&#xD;
&#xD;
         10. A history of prescription drug abuse, or illicit drug use within 6 months prior to&#xD;
             screening;&#xD;
&#xD;
         11. A history of alcohol abuse according to medical history within 6 months prior to&#xD;
             screening;&#xD;
&#xD;
         12. A positive screen for alcohol, drugs of abuse;&#xD;
&#xD;
         13. Tobacco use within 6 months prior to screening based on subject report;&#xD;
&#xD;
         14. Subjects with hypersensitivity to PRISTIQ or medicines containing desvenlafaxine or&#xD;
             its precursor venlafaxine;&#xD;
&#xD;
         15. Subjects who have participated in a previous clinical study of either LY03005 or&#xD;
             PRISTIQ or medicines containing desvenlafaxine or its precursor, venlafaxine within 30&#xD;
             days prior to screening;&#xD;
&#xD;
         16. An unwillingness or inability to comply with food and beverage restrictions during&#xD;
             study participation;&#xD;
&#xD;
         17. Donation or blood collection of more than 1 unit (approximate 450 mL) of blood (or&#xD;
             blood products) or acute loss of blood during the 90 days prior to screening;&#xD;
&#xD;
         18. Use of prescription or over-the-counter (OTC) medications, and herbal (including St&#xD;
             John's Wort, herbal teas, garlic extracts) within 14 days prior to dosing (Note: Use&#xD;
             of acetaminophen at &lt; 3g/day is permitted until 24 hours prior to dosing).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Simon Li, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Luye Pharma Group Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinilabs, Inc.</name>
      <address>
        <city>Eatontown</city>
        <state>New Jersey</state>
        <zip>07724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>March 17, 2017</last_update_submitted>
  <last_update_submitted_qc>March 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Desvenlafaxine Succinate</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/NCT02988024
org study id: LY03005/CT-USA-103
nct id: NCT02988024
lead sponsor: 
has dmc: No
The objects of this study is to assess the relative bioavailability (BA) of 80 mg LY03005
      oral tablets compared to 50 mg Pristiq® oral tablets after a single oral intake under fasting
      conditions in healthy subjects between 18 and 50 years of age.
Twenty (20) eligible subjects will be enrolled and assigned to either LY03005 group or
      Pristiq group at a 1:1 ratio at one site in the USA.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under curve (AUC) for the Pharmacokinetics (PK) of LY03005
time frame: 4 days
description: PK Samples drawn at 0 (within 30 minutes prior to dosing), 1,2,3,4 (+/- 5 min), 6,8,10,12,23,32,48 and 72 hours (+/- 15 min) after dosing.
arm group label: LY03005
arm group type: Experimental
description: LY03005 80 mg
arm group label: Pristiq
arm group type: Active Comparator
description: Pristiq 50 mg
intervention type: Drug
intervention name: LY03005
description: LY03005
arm group label: LY03005
intervention type: Drug
intervention name: Pristiq
arm group label: Pristiq
other name: Desvenlafaxine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Simon Li, M.D.
role: Study Chair
affiliation: Luye Pharma Group Ltd.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depressive Disorder, Major
mesh term: Desvenlafaxine Succinate