<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/NCT01697436</url>
  </required_header>
  <id_info>
    <org_study_id>BP28307</org_study_id>
    <nct_id>NCT01697436</nct_id>
  </id_info>
  <brief_title>A Bioequivalence Study of an Oral Solution of Copegus (Ribavirin) Compared to Copegus Tablets</brief_title>
  <official_title>A Bioequivalence Study of Ribavirin Oral Solution (RO0209963) Versus the Reference Ribavirin Tablets (Copegus) Following Oral Administration in Healthy Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This four-period, single-center, open-label, single-dose, randomized, cross-over study will&#xD;
      assess the bioequivalence and safety of an oral solution of Copegus (ribavirin) compared to a&#xD;
      Copegus tablet in healthy adult volunteers. Volunteers will be randomized to one of four&#xD;
      sequences in which they will receive the treatment under fed and under fasted conditions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics: area under the plasma concentration time curve</measure>
    <time_frame>Periods 1-4: Predose and up to 192 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: maximum plasma concentration</measure>
    <time_frame>Periods 1-4: Predose and up to 192 hours post-dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety: incidence of adverse events</measure>
    <time_frame>Approximately 16 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Healthy Volunteer</condition>
  <arm_group>
    <arm_group_label>Crossover Period 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Crossover Period 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Crossover Period 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Crossover Period 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ribavirin [Copegus]</intervention_name>
    <description>tablet under fed condition</description>
    <arm_group_label>Crossover Period 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ribavirin [Copegus]</intervention_name>
    <description>tablet under fasted condition</description>
    <arm_group_label>Crossover Period 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ribavirin [Copegus]</intervention_name>
    <description>oral solution under fed condition</description>
    <arm_group_label>Crossover Period 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ribavirin [Copegus]</intervention_name>
    <description>oral solution under fasted condition</description>
    <arm_group_label>Crossover Period 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult healthy volunteers&#xD;
&#xD;
          -  Able to participate and willing to give informed consent and comply with the study&#xD;
             restrictions.&#xD;
&#xD;
          -  Negative urine pregnancy test (for women of childbearing potential) documented at&#xD;
             screening and within the 24-hour period prior to each dose of test drug&#xD;
&#xD;
          -  All male subjects with female partners of childbearing potential must agree to use two&#xD;
             reliable forms of contraception, one of which must be a physical barrier method,&#xD;
             during the study and for 6 months thereafter&#xD;
&#xD;
          -  Female subjects must be postmenopausal or surgically sterile or they must agree to use&#xD;
             two reliable forms of contraception one of which must be a physical barrier method,&#xD;
             during treatment and for 6 months thereafter&#xD;
&#xD;
          -  Body mass index (BMI) &lt;30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating women and male partners of females who are pregnant or lactating&#xD;
&#xD;
          -  Positive test for drugs of abuse at screening and within the 24-hour period prior to&#xD;
             each dose of test drug.&#xD;
&#xD;
          -  History (within 3 months of screening) of alcohol consumption exceeding 2 standard&#xD;
             units per day on average (1 standard unit = 10 grams of alcohol). Alcohol consumption&#xD;
             will be prohibited at least 48 hours before screening and from at least 48 hours&#xD;
             before Day -1 through the end of the study&#xD;
&#xD;
          -  Confirmed systolic blood pressure (SBP) &gt; 140 or &lt; 90 mm Hg, and diastolic blood&#xD;
             pressure (DBP) &gt; 90 or &lt; 50 mm Hg&#xD;
&#xD;
          -  Resting pulse rate &gt; 90 or &lt; 45 beats per minute&#xD;
&#xD;
          -  History or symptoms of any significant disease including (but not limited to)&#xD;
             hematological, neurological, psychiatric, cardiovascular, respiratory,&#xD;
             gastrointestinal, hepatic, or renal disorder&#xD;
&#xD;
          -  History of active malignancy within the last 5 years, with the exception of localized&#xD;
             or in situ carcinoma of the skin (e.g., skin basal or squamous cell carcinoma)&#xD;
&#xD;
          -  Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or&#xD;
             human immunodeficiency virus antibody (HIV Ab) at screening&#xD;
&#xD;
          -  Use of any medications (prescription or over-the-counter, vitamin, mineral, herbal,&#xD;
             and dietary supplements within 7 days, or less than 5 half-lives (whichever is longer)&#xD;
             prior to randomization. Exceptions are acetaminophen (up to 2 g/day), ibuprofen (up to&#xD;
             1 g/day), and hormonal contraceptives.&#xD;
&#xD;
          -  Clinically significant abnormalities in laboratory test results&#xD;
&#xD;
          -  Participation in an investigational drug study within 60 days or in an investigational&#xD;
             device study within 30 days prior to screening&#xD;
&#xD;
          -  Donation of blood over 500 mL from 3 months prior to screening until the end of the&#xD;
             study; donation of plasma from 7 days prior to screening until the end of the study&#xD;
&#xD;
          -  Concomitant disease or condition that could interfere with, or for which the treatment&#xD;
             of might interfere with, the conduct of the study or that would, in the opinion of the&#xD;
             Investigator, pose an unacceptable risk to the subject in this study&#xD;
&#xD;
          -  Smoker of more than 10 cigarettes per day prior to screening or use of tobacco&#xD;
             products equivalent to more than 10 cigarettes per day&#xD;
&#xD;
          -  Clinically significant abnormalities in the pre-dose resting electrocardiograms&#xD;
&#xD;
          -  Any confirmed significant allergic reactions against RBV or known or potential allergy&#xD;
             or hypersensitivity to the non-active ingredients of the study drugs (non-active hay&#xD;
             fever is acceptable)&#xD;
&#xD;
          -  Individuals receiving ribavirin therapy within 6 months prior to study initiation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Lenexa</city>
        <state>Kansas</state>
        <zip>66219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>November 1, 2016</last_update_submitted>
  <last_update_submitted_qc>November 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ribavirin</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/NCT01697436
org study id: BP28307
nct id: NCT01697436
lead sponsor: 
This four-period, single-center, open-label, single-dose, randomized, cross-over study will
      assess the bioequivalence and safety of an oral solution of Copegus (ribavirin) compared to a
      Copegus tablet in healthy adult volunteers. Volunteers will be randomized to one of four
      sequences in which they will receive the treatment under fed and under fasted conditions.
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Pharmacokinetics: area under the plasma concentration time curve
time frame: Periods 1-4: Predose and up to 192 hours post-dose
measure: Pharmacokinetics: maximum plasma concentration
time frame: Periods 1-4: Predose and up to 192 hours post-dose
measure: Safety: incidence of adverse events
time frame: Approximately 16 weeks
arm group label: Crossover Period 1
arm group type: Experimental
arm group label: Crossover Period 2
arm group type: Experimental
arm group label: Crossover Period 3
arm group type: Experimental
arm group label: Crossover Period 4
arm group type: Experimental
intervention type: Drug
intervention name: ribavirin [Copegus]
description: tablet under fed condition
arm group label: Crossover Period 1
intervention type: Drug
intervention name: ribavirin [Copegus]
description: tablet under fasted condition
arm group label: Crossover Period 2
intervention type: Drug
intervention name: ribavirin [Copegus]
description: oral solution under fed condition
arm group label: Crossover Period 3
intervention type: Drug
intervention name: ribavirin [Copegus]
description: oral solution under fasted condition
arm group label: Crossover Period 4
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
country: United States
responsible party type: Sponsor
mesh term: Ribavirin