<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/NCT02969252</url>
  </required_header>
  <id_info>
    <org_study_id>CB-01-11/27</org_study_id>
    <nct_id>NCT02969252</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics and Safety Study of Rifamycin SV-MMX® 600 mg Tablets After Single and Multiple t.i.d. Doses in Healthy Male and Female Volunteers</brief_title>
  <official_title>Pharmacokinetics and Safety Study of Rifamycin SV-MMX® 600 mg Tablets After Single and Multiple t.i.d. Doses in Healthy Male and Female Volunteers. Single and Multiple Dose, Open Label, Pharmacokinetics and Safety Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cosmo Technologies Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CosmoTech</source>
  <brief_summary>
    <textblock>
      The objective of the study was to evaluate the pharmacokinetics and the safety of rifamycin&#xD;
      SV after single and multiple doses of Rifamycin SV-MMX® 600 mg tablets administered to male&#xD;
      and female healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2015</start_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <phase>Phase 1</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>Day 1</time_frame>
    <description>Cmax,0-24 h</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>Day 1</time_frame>
    <description>Cmax,0-6</description>
  </primary_outcome>
  <primary_outcome>
    <measure>tmax</measure>
    <time_frame>Day 1</time_frame>
    <description>tmax,0-24</description>
  </primary_outcome>
  <primary_outcome>
    <measure>tmax</measure>
    <time_frame>Day 1</time_frame>
    <description>tmax,0-6</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC</measure>
    <time_frame>Day 1</time_frame>
    <description>AUC 0-24</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC</measure>
    <time_frame>Day 1</time_frame>
    <description>AUC 0-6</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Open label</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Single and multiple dose, open label, pharmacokinetics and safety study</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rifamycin SV-MMX® 600</intervention_name>
    <arm_group_label>Open label</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Informed consent: signed written informed consent before inclusion in the study&#xD;
&#xD;
          2. Sex and Age: men and women, 18-55 year old inclusive&#xD;
&#xD;
          3. Body Mass Index: 18.5-30 kgm2 inclusive&#xD;
&#xD;
          4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89&#xD;
             mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position&#xD;
&#xD;
          5. Full comprehension: ability to comprehend the full nature and purpose of the study,&#xD;
             including possible risks and side effects; ability to co-operate with the investigator&#xD;
             and to comply with the requirements of the entire study&#xD;
&#xD;
          6. Fertility (women only): women of non-child-bearing potential or in post-menopausal&#xD;
             status for at least 1 year.&#xD;
&#xD;
        For all female subjects, pregnancy test result had to be negative at screening and Day -1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. ECG 12-leads (supine position): clinically significant abnormalities&#xD;
&#xD;
          2. Physical findings: clinically significant abnormal physical findings which could&#xD;
             interfere with the objectives of the study&#xD;
&#xD;
          3. Laboratory analyses: clinically significant abnormal laboratory values indicative of&#xD;
             physical illness&#xD;
&#xD;
          4. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or&#xD;
             formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in&#xD;
             general, which the investigator considered could affect the outcome of the study&#xD;
&#xD;
          5. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular,&#xD;
             respiratory, skin, haematological, endocrine or neurological diseases that could&#xD;
             interfere with the aim of the study&#xD;
&#xD;
          6. Medications: medications, including over the counter medications and herbal remedies,&#xD;
             for 2 weeks before the start of the study&#xD;
&#xD;
          7. Investigative drug studies: participation in the evaluation of any investigational&#xD;
             product for 3 months before this study. The 3-month interval was calculated as the&#xD;
             time between the first calendar day of the month that follows the last visit of the&#xD;
             previous study and the first day of the present study&#xD;
&#xD;
          8. Blood donation: blood donations for 3 months before this study&#xD;
&#xD;
          9. Drug, alcohol, caffeine, tobacco: history of drug, alcohol (more than 1 drink a day&#xD;
             for females and more than 2 drinks a day for males, defined according to the USDA&#xD;
             Dietary Guidelines 2010), caffeine (more than 5 cups coffee/tea/day) or tobacco abuse&#xD;
             (10 cigarettes a day)&#xD;
&#xD;
         10. Abuse drug test: positive result at the drug test at screening or Day-1&#xD;
&#xD;
         11. Alcohol test: positive alcohol breath test at Day -1&#xD;
&#xD;
         12. Diet: abnormal diets (less than1600 or more than 3500 kcal/day) or substantial changes&#xD;
             in eating habits in the 4 weeks before this study; vegetarians&#xD;
&#xD;
         13. Pregnancy (females only): positive or missing pregnancy test at screening or Day -1,&#xD;
             pregnant or lactating women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>January 24, 2018</last_update_submitted>
  <last_update_submitted_qc>January 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2018</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>Rifamycins</mesh_term>
    <mesh_term>Rifamycin SV</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/NCT02969252
org study id: CB-01-11/27
nct id: NCT02969252
lead sponsor: 
The objective of the study was to evaluate the pharmacokinetics and the safety of rifamycin
      SV after single and multiple doses of Rifamycin SV-MMX® 600 mg tablets administered to male
      and female healthy subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Cmax
time frame: Day 1
description: Cmax,0-24 h
measure: Cmax
time frame: Day 1
description: Cmax,0-6
measure: tmax
time frame: Day 1
description: tmax,0-24
measure: tmax
time frame: Day 1
description: tmax,0-6
measure: AUC
time frame: Day 1
description: AUC 0-24
measure: AUC
time frame: Day 1
description: AUC 0-6
arm group label: Open label
arm group type: Other
description: Single and multiple dose, open label, pharmacokinetics and safety study
intervention type: Drug
intervention name: Rifamycin SV-MMX® 600
arm group label: Open label
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Rifamycins
mesh term: Rifamycin SV