<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/NCT02255734</url>
  </required_header>
  <id_info>
    <org_study_id>YSP-REH3002-01</org_study_id>
    <nct_id>NCT02255734</nct_id>
  </id_info>
  <brief_title>Bioequivalence of Two Formulations of Acyclovir</brief_title>
  <official_title>Bioequivalence of Two Formulations of Acyclovir</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yung Shin Pharm. Ind. Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yung Shin Pharm. Ind. Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bioequivalence of two formulations of Acyclovir (Acyclovir Lyophilized I.V. infusion 250mg)&#xD;
      after Intravenous Infusion in Healthy Volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>Phase 4</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>Plasma drug concentration</measure>
    <time_frame>Day 1, Day 2</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Zovirax</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Virless</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acyclovir</intervention_name>
    <arm_group_label>Virless</arm_group_label>
    <arm_group_label>Zovirax</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adult male or female subjects between 20 to 45 years of age&#xD;
&#xD;
          -  Body weight within 80 to 120 percentages of ideal body weight and higher than or equal&#xD;
             to 50 kg for male subjects and 45 kg for female subjects&#xD;
&#xD;
          -  Acceptable medical history and physical examination including no particular clinically&#xD;
             significant abnormality in x-ray and ECG results within six months prior to period I&#xD;
             dosing.no particular clinical significance in general disease history within two&#xD;
             months prior to period I dosing&#xD;
&#xD;
          -  Acceptable vital signs within normal limits or considered by the investigator or&#xD;
             physician to be of no clinical significance at screening, which includes pulse rate,&#xD;
             blood pressure and body temperature&#xD;
&#xD;
          -  Acceptable clinical chemistry determinations within normal limits or considered by the&#xD;
             investigator or physician to be of no clinical significance within two months prior to&#xD;
             Period I dosing, which includes AST , ALT ,GT, alkaline phosphatase, total bilirubin,&#xD;
             albumin, glucose, BUN, uric acid, creatinine, total cholesterol and triglyceride&#xD;
&#xD;
          -  Acceptable hematology within normal range or considered by the investigator or&#xD;
             physician to be of no clinical significance within two months prior to Period I&#xD;
             dosing, which includes hemoglobin, hematocrit, red blood cell count, white blood cell&#xD;
             count with differentials and platelets&#xD;
&#xD;
          -  Acceptable urinalysis within normal limits or considered by the investigator or&#xD;
             physician to be of no clinical significance within two months prior to Period I&#xD;
             dosing, which includes pH, blood, glucose, ketones, bilirubin and protein&#xD;
&#xD;
          -  Female subjects of childbearing potential practicing an acceptable method of birth&#xD;
             control for the duration of the study as judged by the investigators or surgically&#xD;
             sterile bilateral tubal ligation, bilateral oophorectomy or hysterectomy performed on&#xD;
             the subject&#xD;
&#xD;
          -  Have signed the written informed consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A clinically significant disorder involving the cardiovascular, respiratory, hepatic,&#xD;
             renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic systems or&#xD;
             psychiatric disease as determined by the clinical investigator&#xD;
&#xD;
          -  A clinically significant illness or surgery within four weeks prior to Period I dosing&#xD;
             as determined by the investigator&#xD;
&#xD;
          -  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;
          -  History of kidney disease or urination problem over last two years deemed by the&#xD;
             investigator to be clinically significant&#xD;
&#xD;
          -  Known or suspected history of drug abuse within lifetime as judged by the investigator&#xD;
&#xD;
          -  History of alcohol addiction or abuse within last five years as judged by the&#xD;
             investigator&#xD;
&#xD;
          -  History of allergic responses to acyclovir, valacyclovir or any other related drugs&#xD;
&#xD;
          -  Evidence of chronic or acute infectious diseases&#xD;
&#xD;
          -  Female subjects demonstrating a positive urine pregnancy screen prior to the study&#xD;
&#xD;
          -  Female subjects who are currently breastfeeding&#xD;
&#xD;
          -  Taking any drug known to induce or inhibit hepatic drug metabolism within four weeks&#xD;
             prior to Period I dosing. Examples of inducers include. piperidines, carbamazepine,&#xD;
             dexamethasone and rifampin. Examples of inhibitors include: cimetidine,&#xD;
             diphenhydramine, fluvastatin, methadone and ranitidine&#xD;
&#xD;
          -  Taking any prescription medications within four weeks or any nonprescription&#xD;
             medications excluding flu vaccination within two weeks prior to Period I dosing&#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>
  <overall_official>
    <last_name>Po-Yen Chen, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taichung Veterans General Hospital</affiliation>
  </overall_official>
  <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>September 2014</verification_date>
  <study_first_submitted>May 14, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>September 29, 2014</last_update_submitted>
  <last_update_submitted_qc>September 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Volunteers</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acyclovir</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/NCT02255734
org study id: YSP-REH3002-01
nct id: NCT02255734
lead sponsor: 
has dmc: No
Bioequivalence of two formulations of Acyclovir (Acyclovir Lyophilized I.V. infusion 250mg)
      after Intravenous Infusion in Healthy Volunteers.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Plasma drug concentration
time frame: Day 1, Day 2
arm group label: Zovirax
arm group type: Active Comparator
arm group label: Virless
arm group type: Experimental
intervention type: Drug
intervention name: Acyclovir
arm group label: Virless
arm group label: Zovirax
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Po-Yen Chen, M.D.
role: Principal Investigator
affiliation: Taichung Veterans General Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Acyclovir