<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/NCT03826316</url>
  </required_header>
  <id_info>
    <org_study_id>YSP-RJH3002-01</org_study_id>
    <nct_id>NCT03826316</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of Nalbuphine Injection</brief_title>
  <official_title>A Study to Evaluate Pharmacokinetics of Nalbuphine Hydrochloride (10 mg/mL) After a Single Intravenous Administration in Healthy Volunteers Under Fasting Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yung Shin Pharm. Ind. Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Taichung Veterans General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Yung Shin Pharm. Ind. Co., Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study to evaluate pharmacokinetics of nalbuphine hydrochloride (10 mg/mL) after a single&#xD;
      intravenous administration in healthy volunteers under fasting conditions&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2018</start_date>
  <completion_date type="Actual">January 15, 2019</completion_date>
  <primary_completion_date type="Actual">November 22, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the plasma concentration (AUC)</measure>
    <time_frame>Plasma sample: 0, 0.5, 5, 10, 15, 20, 30, 45 minutes, 1, 2, 4, 6, 8, 10 and 12 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak Drug Concentration (Cmax)</measure>
    <time_frame>Plasma sample: 0, 0.5, 5, 10, 15, 20, 30, 45 minutes, 1, 2, 4, 6, 8, 10 and 12 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Elimiation half-life (T1/2)</measure>
    <time_frame>Plasma sample: 0, 0.5, 5, 10, 15, 20, 30, 45 minutes, 1, 2, 4, 6, 8, 10 and 12 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the (first) moment plasma concentration-time curve (AUMC)</measure>
    <time_frame>Plasma sample: 0, 0.5, 5, 10, 15, 20, 30, 45 minutes, 1, 2, 4, 6, 8, 10 and 12 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Adverse event reporting will up to 10 weeks.</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Mutonpain Injection 10 mg/ml</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nalbuphine</intervention_name>
    <description>Pharmacokinetic study under fasting conditions</description>
    <arm_group_label>Mutonpain Injection 10 mg/ml</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy adult male subjects between 20-45 years of age.&#xD;
&#xD;
          2. Body weight within 80-120% of ideal body weight.&#xD;
&#xD;
             * Ideal body weight (kg) = [height (cm) - 80] *0.7 for male subjects&#xD;
&#xD;
          3. Acceptable medical history and physical examination including:&#xD;
&#xD;
               -  no particular clinically significant abnormalities in chest x-ray and&#xD;
                  electrocardiogram results within six months prior to study drug dosing.&#xD;
&#xD;
               -  no particular clinical significance in general disease history within two months&#xD;
                  prior to study drug dosing.&#xD;
&#xD;
          4. Acceptable biochemistry determinations (within normal limits or considered by the&#xD;
             investigator or physician to be of no clinical significance) within two months prior&#xD;
             to study drug dosing, which includes Serum Glutamic Oxaloacetic Transaminase (SGOT,&#xD;
             same as AST), Serum Glutamic Pyruvic Transaminase (SGPT, same as ALT),&#xD;
             Gamma-Glutamyl-Transpeptidase (γ-GT), alkaline phosphatase, total bilirubin, albumin,&#xD;
             glucose, Blood Urea Nitrogen(BUN), uric acid, creatinine, total cholesterol and&#xD;
             triglyceride (TG).&#xD;
&#xD;
          5. Acceptable hematology (within normal limits or considered by the investigator or&#xD;
             physician to be of no clinical significance) within two months prior to study drug&#xD;
             dosing, which includes hemoglobin, hematocrit, red blood cell count, white blood cell&#xD;
             count with differentials and platelets.&#xD;
&#xD;
          6. Acceptable urinalysis (within normal limits or considered by the investigator or&#xD;
             physician to be of no clinical significance) within two months prior to study drug&#xD;
             dosing, which includes power of hydrogen (pH), blood, glucose, ketones, bilirubin and&#xD;
             protein.&#xD;
&#xD;
          7. Male subjects willing to use a condom during any sexual contact with females of&#xD;
             reproductive potential for up to 10 weeks after study drug dosing.&#xD;
&#xD;
          8. Have signed the written informed consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A clinically significant disorder involving the cardiovascular, respiratory, hepatic,&#xD;
             renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s)&#xD;
             or psychiatric disease (as determined by the investigator).&#xD;
&#xD;
          2. A clinically significant illness or surgery within four weeks prior to dosing (as&#xD;
             determined by the investigator).&#xD;
&#xD;
          3. History of gastrointestinal obstruction, inflammatory bowel disease, gallbladder&#xD;
             disease, pancreas disorder over last two years or history of gastrointestinal tract&#xD;
             surgery over last five years.&#xD;
&#xD;
          4. History of kidney disease or urination problem over last two years deemed by the&#xD;
             investigator to be clinically significant.&#xD;
&#xD;
          5. Known or suspected history of drug abuse within lifetime as judged by the&#xD;
             investigator.&#xD;
&#xD;
          6. History of alcohol addiction or abuse within last five years as judged by the&#xD;
             investigator.&#xD;
&#xD;
          7. History of allergic response(s) to nalbuphine hydrochloride or any other related&#xD;
             drugs.&#xD;
&#xD;
          8. Evidence of chronic or acute infectious disease.&#xD;
&#xD;
          9. Positive results for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody&#xD;
             (HCVAb), or human immunodeficiency virus (HIV).&#xD;
&#xD;
         10. Female subjects demonstrating a positive pregnancy screen prior to the study.&#xD;
&#xD;
         11. Female subjects who are currently breastfeeding.&#xD;
&#xD;
         12. Taking any drug known to induce or inhibit hepatic drug metabolism within four weeks&#xD;
             prior to dosing. Examples of inducers include: piperidines, carbamazepine,&#xD;
             dexamethasone and rifampin. Examples of inhibitors include: cimetidine,&#xD;
             diphenhydramine, fluvastatin, methadone and ranitidine.&#xD;
&#xD;
         13. Taking any prescription medications within four weeks or any nonprescription&#xD;
             medications (excluding flu vaccination) within two weeks prior to dosing.&#xD;
&#xD;
         14. Use of any investigational drug within four weeks prior to dosing.&#xD;
&#xD;
         15. Donating more than 250 milliliter (mL) of blood within two months prior to dosing or&#xD;
             donating plasma (e.g. plasmapheresis) within two weeks prior to dosing.&#xD;
&#xD;
         16. Any other medical reason as determined by the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 27, 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>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pharmacokinetic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nalbuphine</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/NCT03826316
org study id: YSP-RJH3002-01
nct id: NCT03826316
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
A study to evaluate pharmacokinetics of nalbuphine hydrochloride (10 mg/mL) after a single
      intravenous administration in healthy volunteers under fasting conditions
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the plasma concentration (AUC)
time frame: Plasma sample: 0, 0.5, 5, 10, 15, 20, 30, 45 minutes, 1, 2, 4, 6, 8, 10 and 12 hours
measure: Peak Drug Concentration (Cmax)
time frame: Plasma sample: 0, 0.5, 5, 10, 15, 20, 30, 45 minutes, 1, 2, 4, 6, 8, 10 and 12 hours
measure: Elimiation half-life (T1/2)
time frame: Plasma sample: 0, 0.5, 5, 10, 15, 20, 30, 45 minutes, 1, 2, 4, 6, 8, 10 and 12 hours
measure: Area under the (first) moment plasma concentration-time curve (AUMC)
time frame: Plasma sample: 0, 0.5, 5, 10, 15, 20, 30, 45 minutes, 1, 2, 4, 6, 8, 10 and 12 hours
measure: Adverse events
time frame: Adverse event reporting will up to 10 weeks.
arm group label: Mutonpain Injection 10 mg/ml
arm group type: Experimental
intervention type: Drug
intervention name: Nalbuphine
description: Pharmacokinetic study under fasting conditions
arm group label: Mutonpain Injection 10 mg/ml
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Nalbuphine