<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/NCT02192151</url>
  </required_header>
  <id_info>
    <org_study_id>PH-CP019</org_study_id>
    <nct_id>NCT02192151</nct_id>
  </id_info>
  <brief_title>Study of PHN131 in Healthy Volunteers</brief_title>
  <official_title>The Pharmacokinetic and Bioavailability Studies of PHN131, an Oral Formulation of Nalbuphine Hydrochloride, in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PhytoHealth Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PhytoHealth Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety and to investigate the pharmacokinetic properties and bioavailability&#xD;
      of PHN131 in healthy volunteers&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Efficacy endpoint(s): the pharmacokinetic properties and bioavailability of PHN131 The&#xD;
           efficacy endpoint will be the pharmacokinetic properties after administered PHN131 such&#xD;
           as the concentration of nalbuphine in plasma and pharmacokinetic parameters of PHN131&#xD;
           analyzed from the concentration of nalbuphine in plasma. The bioavailability of PHN131&#xD;
           will be calculated from the pharmacokinetic parameters of PHN131 and Nubain® injection.&#xD;
&#xD;
        2. Safety evaluation:&#xD;
&#xD;
      The safety evaluation will include the vital signs monitoring such as blood pressure, pulse&#xD;
      rate, body temperature and respiratory rate in the treatment period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Not completed its inspection.(CSR completed)&#xD;
  </why_stopped>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2011</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy endpoint(s)</measure>
    <time_frame>10 days</time_frame>
    <description>The pharmacokinetic properties and bioavailability of PHN131 The efficacy endpoint will be the pharmacokinetic properties after administered PHN131 such as the concentration of nalbuphine in plasma and pharmacokinetic parameters of PHN131 analyzed from the concentration of nalbuphine in plasma. The bioavailability of PHN131 will be calculated from the pharmacokinetic parameters of PHN131 and Nubain® injection.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety evaluation</measure>
    <time_frame>10 days</time_frame>
    <description>The safety evaluation will include the vital signs monitoring such as blood pressure, pulse rate, body temperature and respiratory rate in the treatment period.</description>
  </secondary_outcome>
  <enrollment type="Actual">16</enrollment>
  <condition>Analgesia Disorder</condition>
  <eligibility>
    <study_pop>
      <textblock>
        18&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Each subject must meet the following criteria to be enrolled in the study:&#xD;
&#xD;
          1. Normal healthy adult subjects between 20 to 40 years of age.&#xD;
&#xD;
          2. Body weight within 80 to 120% of ideal body weight. The ideal body weight is defined&#xD;
             as: (subjects' height - 80) x 0.7&#xD;
&#xD;
          3. Acceptable medical history and physical examination including:&#xD;
&#xD;
               -  Normal chest X-ray and ECG results within six months prior to the Treatment&#xD;
                  Period of dose.&#xD;
&#xD;
               -  No particular clinical significance in general disease history within two months&#xD;
                  prior to the Treatment Period of dose.&#xD;
&#xD;
          4. Acceptable clinical laboratory determinations without significant deviation from&#xD;
             normal values within two months prior to the Treatment Period of dose, which includes&#xD;
             AST, ALT, garma-GT, alkaline phosphatase, total bilirubin, albumin glucose, BUN, uric&#xD;
             acid, creatinine, total cholesterol and triglyceride (TG).&#xD;
&#xD;
          5. Acceptable hematology within two months prior to the study, which includes hemoglobin,&#xD;
             hematocrit, red blood cells, MCV, MCH, MCHC, white blood cells and platelets.&#xD;
&#xD;
          6. Acepatable urinalysis within two months prior to the study, which includes pH, urine&#xD;
             glucose and protein.&#xD;
&#xD;
          7. Signed the written informed consent to participate in this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects meeting any of the following criteria will be excluded from the study:&#xD;
&#xD;
          1. Recent history of drug or alcohol addiction or abuse.&#xD;
&#xD;
          2. A clinically significant disorder involving the cardiovascular, respiratory, renal,&#xD;
             gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or&#xD;
             psychiatric disease (as determined by the clinical investigator).&#xD;
&#xD;
          3. History of allergic response(s) to nalbuphine or related drugs.&#xD;
&#xD;
          4. History of clinically significant allergies including drug allergies or allergic&#xD;
             bronchial asthma.&#xD;
&#xD;
          5. Evidence of chronic or acute infectious disease.&#xD;
&#xD;
          6. Any clinically significant illness or surgery during the 4 weeks prior to the&#xD;
             Treatment Period of dose (as determined by the clinical investigator).&#xD;
&#xD;
          7. Taking any drugs known to induce and/or inhibit hepatic drug metabolism within one&#xD;
             month prior to the Treatment Period of dose.&#xD;
&#xD;
          8. Receiving any investigational drug within one month prior to the Treatment Period of&#xD;
             dose.&#xD;
&#xD;
          9. Taking any prescription medication or any nonprescription medication within two weeks&#xD;
             prior to the Treatment Period of dose.&#xD;
&#xD;
         10. Donating greater than 150 ml of blood within two months prior to the Treatment Period&#xD;
             of dose or donating plasma (e.g. plasmapheresis) within 14 days prior to the Treatment&#xD;
             Period of dose. All subjects will be advised not to donate blood for 4 weeks after&#xD;
             completing the study.&#xD;
&#xD;
         11. Consumption of caffeine, xanthine-containing products (i.e. coffee, tea,&#xD;
             caffeine-containing sodas, colas and chocolates, etc.) and/or alcohol at least 48&#xD;
             hours prior to day on which dosing is scheduled and during the periods when blood&#xD;
             samples are being collected.&#xD;
&#xD;
         12. Any other medical reason(s) as determined by the clinical investigator.&#xD;
&#xD;
         13. Patient is pregnant or breastfeeding. Women of childbearing potential have positive&#xD;
             urine pregnancy test at baseline.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shung-Tai Ho, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tri-service General Hospital &amp; National Defense Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>General Clinical Research Center, Tri-service General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>114</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>November 24, 2013</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 14, 2014</last_update_submitted>
  <last_update_submitted_qc>July 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Analgesic</keyword>
  <keyword>Narcotics</keyword>
  <keyword>Opioids</keyword>
  <keyword>Non-scheduled substanse</keyword>
  <!-- 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/NCT02192151
org study id: PH-CP019
nct id: NCT02192151
lead sponsor: 
has dmc: No
To evaluate the safety and to investigate the pharmacokinetic properties and bioavailability
      of PHN131 in healthy volunteers
1. Efficacy endpoint(s): the pharmacokinetic properties and bioavailability of PHN131 The
           efficacy endpoint will be the pharmacokinetic properties after administered PHN131 such
           as the concentration of nalbuphine in plasma and pharmacokinetic parameters of PHN131
           analyzed from the concentration of nalbuphine in plasma. The bioavailability of PHN131
           will be calculated from the pharmacokinetic parameters of PHN131 and Nubain® injection.

        2. Safety evaluation:

      The safety evaluation will include the vital signs monitoring such as blood pressure, pulse
      rate, body temperature and respiratory rate in the treatment period.
observational model: Case-Crossover
time perspective: Prospective
measure: Efficacy endpoint(s)
time frame: 10 days
description: The pharmacokinetic properties and bioavailability of PHN131 The efficacy endpoint will be the pharmacokinetic properties after administered PHN131 such as the concentration of nalbuphine in plasma and pharmacokinetic parameters of PHN131 analyzed from the concentration of nalbuphine in plasma. The bioavailability of PHN131 will be calculated from the pharmacokinetic parameters of PHN131 and Nubain® injection.
measure: Safety evaluation
time frame: 10 days
description: The safety evaluation will include the vital signs monitoring such as blood pressure, pulse rate, body temperature and respiratory rate in the treatment period.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shung-Tai Ho, Ph.D
role: Principal Investigator
affiliation: Tri-service General Hospital & National Defense Medical Center
facility: 
country: Taiwan
responsible party type: Sponsor