<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/NCT04468282</url>
  </required_header>
  <id_info>
    <org_study_id>ORP-VGB-I-a</org_study_id>
    <secondary_id>2017-000038-67</secondary_id>
    <nct_id>NCT04468282</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study of Vigabatrin ORPHELIA Pharma 500mg Soluble Tablets and SabrilTM 500mg Granules for Oral Administration</brief_title>
  <official_title>Bioequivalence Study of Vigabatrin ORPHELIA Pharma 500mg Soluble Tablets and SabrilTM 500mg Granules for Oral Administration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Orphelia Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Orphelia Pharma</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Methodology:&#xD;
&#xD;
      The study was an open label, randomized, crossover, 2 periods study in 20 healthy male/female&#xD;
      volunteers. Subjects received 500 mg of the new formulation of soluble tablets vigabatrin or&#xD;
      Sabril, as single oral administration in 2 different study periods depending on the&#xD;
      randomization, with a 7-days wash out period between administrations&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives:&#xD;
&#xD;
      Primary objective:&#xD;
&#xD;
      Evaluate bioequivalence between a new paediatric formulation of vigabatrin (VGB-ST) and&#xD;
      Sabril granules for oral administration.&#xD;
&#xD;
      Secondary objective:&#xD;
&#xD;
        -  Define pharmacokinetic parameters of the new paediatric formulation soluble tablets of&#xD;
           vigabatrin (VGB-ST)&#xD;
&#xD;
        -  Assess the safety of the new formulation of soluble tablets VGB-ST versus Sabril&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 4, 2017</start_date>
  <completion_date type="Actual">August 8, 2017</completion_date>
  <primary_completion_date type="Actual">August 8, 2017</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>
    <intervention_model_description>The study was an open label, randomized, crossover, 2 periods study in 20 healthy male/female volunteers. Subjects received 500 mg of the new formulation of soluble tablets vigabatrin or Sabril TM, as single oral administration in 2 different study periods depending on the randomization, with a 7-days wash out period between administrations.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary pharmacokinetic parameters (Bioequivalence)</measure>
    <time_frame>day 1 or 2</time_frame>
    <description>The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: Cmax</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary pharmacokinetic parameters (Bioequivalence)</measure>
    <time_frame>day 1 or 2</time_frame>
    <description>The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: AUC0-t</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary pharmacokinetic parameters</measure>
    <time_frame>day 1 or 2</time_frame>
    <description>The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: AUC0-inf</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary pharmacokinetic parameters</measure>
    <time_frame>day 1 or 2</time_frame>
    <description>The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: tmax</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary pharmacokinetic parameters</measure>
    <time_frame>day 1 or 2</time_frame>
    <description>The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: λ</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary pharmacokinetic parameters</measure>
    <time_frame>day 1 or 2</time_frame>
    <description>The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: t1/2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary pharmacokinetic parameters</measure>
    <time_frame>day 1 or 2</time_frame>
    <description>The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: residual area</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Therapeutic Equivalency</condition>
  <arm_group>
    <arm_group_label>VGB-ST</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Name of the compound: Vigabatrin ORPHELIA Pharma (VGB-ST) Pharmaceutical form: Soluble tablet Dose per administration: 500 mg Timing for administration: Single oral administration on P1D1 or P2D1 according to randomization.&#xD;
Batch N°: 16.92.042 (expiry date: 31.05.2017)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sabril</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Name of the compound: Sabril (vigabatrin) Pharmaceutical form: granules (sachet) Dose per administration: 500 mg Timing for administration: Single oral administration on P1D1 or P2D1 according to randomization.&#xD;
Batch N°: 6810 (expiry date: 31.05.2019)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VGB-ST</intervention_name>
    <description>Single oral administration of 500 mg VGB-ST</description>
    <arm_group_label>Sabril</arm_group_label>
    <arm_group_label>VGB-ST</arm_group_label>
    <other_name>vigabatrin soluble tablets</other_name>
    <other_name>Kigabeq</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male and female subject, aged between 18 and 50 years inclusive;&#xD;
&#xD;
          2. Females of childbearing potential/Sexually active males with partner of childbearing&#xD;
             potential: commitment to consistently and correctly use an acceptable method of birth&#xD;
             control (oral, transdermal, systemic or implant contraception birth control,&#xD;
             intrauterine devices, diaphragm, condoms or abstinence) for the duration of the trial&#xD;
             and for 1 month after the last study drug administration; Females of non-childbearing&#xD;
             potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhoea&#xD;
             duration at least 12 months);&#xD;
&#xD;
          3. Non breast-feeding female and negative pregnancy test at screening baseline;&#xD;
&#xD;
          4. Non-smoker subject or smoker of not more than 5 cigarettes per day;&#xD;
&#xD;
          5. Body Mass Index (BMI) between 18,5 and 25 kg/m2 inclusive;&#xD;
&#xD;
          6. Considered as healthy after a comprehensive clinical assessment (detailed medical&#xD;
             history and complete physical examination);&#xD;
&#xD;
          7. Normal Blood Pressure (BP) and Heart Rate (HR) at the screening visit after 10 minutes&#xD;
             in supine position&#xD;
&#xD;
          8. Normal ECG recording on a 12-lead ECG at the screening visit&#xD;
&#xD;
          9. Laboratory parameters within the normal range of the laboratory (hematological, blood&#xD;
             chemistry tests, urinalysis). Individual values out of the normal range could be&#xD;
             accepted if judged clinically non relevant by the Investigator;&#xD;
&#xD;
         10. Normal dietary habits;&#xD;
&#xD;
         11. Signing a written informed consent prior to selection;&#xD;
&#xD;
         12. Covered by Health Insurance System and / or in compliance with the recommendations of&#xD;
             National Law in force relating to biomedical research.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic,&#xD;
             renal, metabolic, haematological, neurologic, psychiatric, systemic, infectious&#xD;
             disease or psychiatric disorders;&#xD;
&#xD;
          2. Frequent headaches and / or migraine, recurrent nausea and / or vomiting;&#xD;
&#xD;
          3. History of abnormal vision (e.g. reduced visual field, retinopathy, etc…);&#xD;
&#xD;
          4. Abnormal visual field recorded during the inclusion period;&#xD;
&#xD;
          5. Evidence of any clinically significant acute or chronic disease;&#xD;
&#xD;
          6. Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic&#xD;
             postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20&#xD;
             mmHg within two minutes when changing from the supine to the standing position;&#xD;
&#xD;
          7. Surgery or blood donation (including in the frame of a clinical trial) within 2 months&#xD;
             before administration;&#xD;
&#xD;
          8. General anaesthesia within 3 months before administration;&#xD;
&#xD;
          9. Presence or history of drug hypersensitivity, asthma or allergic disease diagnosed and&#xD;
             treated by a physician;&#xD;
&#xD;
         10. Inability to abstain from intensive muscular effort;&#xD;
&#xD;
         11. No possibility of contact in case of emergency;&#xD;
&#xD;
         12. Any drug intake (except paracetamol or contraception) during the last month prior to&#xD;
             the first administration;&#xD;
&#xD;
         13. History or presence of drug or alcohol abuse (alcohol consumption &gt; 40 grams / day);&#xD;
&#xD;
         14. Excessive consumption of beverages containing xanthine bases (&gt; 4 cups or glasses /&#xD;
             day);&#xD;
&#xD;
         15. Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody&#xD;
             (not including HSV), or positive results for Human Immunodeficiency Virus (HIV) 1 or 2&#xD;
             tests;&#xD;
&#xD;
         16. Positive results of screening for drugs of abuse;&#xD;
&#xD;
         17. Subject who, in the judgment of the Investigator, was likely to be non-compliant or&#xD;
             uncooperative during the study, or unable to cooperate because of a language problem,&#xD;
             poor mental development;&#xD;
&#xD;
         18. Exclusion period of a previous study;&#xD;
&#xD;
         19. Administrative or legal supervision;&#xD;
&#xD;
         20. Subject who would receive more than 4500 euros as indemnities for his participation in&#xD;
             biomedical research within the 12 last months, including the indemnities for the&#xD;
             present study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>PharmD PharmD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Orphelia Pharma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eurofins Optimed</name>
      <address>
        <city>Gières</city>
        <zip>38610</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>March 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</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>Vigabatrin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04468282
org study id: ORP-VGB-I-a
secondary id: 2017-000038-67
nct id: NCT04468282
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Methodology:

      The study was an open label, randomized, crossover, 2 periods study in 20 healthy male/female
      volunteers. Subjects received 500 mg of the new formulation of soluble tablets vigabatrin or
      Sabril, as single oral administration in 2 different study periods depending on the
      randomization, with a 7-days wash out period between administrations
Objectives:

      Primary objective:

      Evaluate bioequivalence between a new paediatric formulation of vigabatrin (VGB-ST) and
      Sabril granules for oral administration.

      Secondary objective:

        -  Define pharmacokinetic parameters of the new paediatric formulation soluble tablets of
           vigabatrin (VGB-ST)

        -  Assess the safety of the new formulation of soluble tablets VGB-ST versus Sabril
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: The study was an open label, randomized, crossover, 2 periods study in 20 healthy male/female volunteers. Subjects received 500 mg of the new formulation of soluble tablets vigabatrin or Sabril TM, as single oral administration in 2 different study periods depending on the randomization, with a 7-days wash out period between administrations.
primary purpose: Treatment
masking: None (Open Label)
measure: Primary pharmacokinetic parameters (Bioequivalence)
time frame: day 1 or 2
description: The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: Cmax
measure: Primary pharmacokinetic parameters (Bioequivalence)
time frame: day 1 or 2
description: The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: AUC0-t
measure: Secondary pharmacokinetic parameters
time frame: day 1 or 2
description: The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: AUC0-inf
measure: Secondary pharmacokinetic parameters
time frame: day 1 or 2
description: The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: tmax
measure: Secondary pharmacokinetic parameters
time frame: day 1 or 2
description: The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: λ
measure: Secondary pharmacokinetic parameters
time frame: day 1 or 2
description: The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: t1/2
measure: Secondary pharmacokinetic parameters
time frame: day 1 or 2
description: The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: residual area
arm group label: VGB-ST
arm group type: Experimental
description: Name of the compound: Vigabatrin ORPHELIA Pharma (VGB-ST) Pharmaceutical form: Soluble tablet Dose per administration: 500 mg Timing for administration: Single oral administration on P1D1 or P2D1 according to randomization.
Batch N°: 16.92.042 (expiry date: 31.05.2017)
arm group label: Sabril
arm group type: Active Comparator
description: Name of the compound: Sabril (vigabatrin) Pharmaceutical form: granules (sachet) Dose per administration: 500 mg Timing for administration: Single oral administration on P1D1 or P2D1 according to randomization.
Batch N°: 6810 (expiry date: 31.05.2019)
intervention type: Drug
intervention name: VGB-ST
description: Single oral administration of 500 mg VGB-ST
arm group label: Sabril
arm group label: VGB-ST
other name: vigabatrin soluble tablets
other name: Kigabeq
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: PharmD PharmD, PhD
role: Study Director
affiliation: Orphelia Pharma
facility: 
country: France
responsible party type: Sponsor
mesh term: Vigabatrin
sharing ipd: No