<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/NCT03023852</url>
  </required_header>
  <id_info>
    <org_study_id>CR108252</org_study_id>
    <secondary_id>63623872FLZ1011</secondary_id>
    <secondary_id>2016-004504-62</secondary_id>
    <nct_id>NCT03023852</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Relative Oral Bioavailability of a Single Dose of JNJ-63623872/Oseltamivir Fixed-dose Combination Tablet and Single Agent Concept Formulations of JNJ-63623872 Compared to Their Respective Reference Formulation in Healthy Adult Participants</brief_title>
  <official_title>A Phase 1, Open-label, Randomized, Crossover Study in Two Panels of Healthy Adult Subjects to Assess the Relative Oral Bioavailability of a Single Dose of JNJ-63623872/Oseltamivir Fixed-dose Combination Tablet and Single Agent Concept Formulations of JNJ-63623872 Compared to Their Respective Reference Formulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen-Cilag International NV</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen-Cilag International NV</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this study is to assess the rate and extent of absorption of JNJ63623872&#xD;
      following administration of a single oral dose of 2*300 milligram (mg) given as 2 concept&#xD;
      single agent tablet formulations compared to the administration of 2*300 mg JNJ63623872&#xD;
      reference tablets, under fasted conditions in healthy adult participants and to assess the&#xD;
      rate and extent of absorption of JNJ63623872 and oseltamivir following administration of a&#xD;
      single oral dose of 2*300 mg/37.5 mg JNJ63623872/ oseltamivir given as a concept fixed dose&#xD;
      combination (FDC) tablet formulation compared to the coadministration of 2*300 mg JNJ63623872&#xD;
      tablets (reference formulation) and 1*75 mg oseltamivir capsule, under fasted conditions in&#xD;
      healthy adult participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 14, 2017</start_date>
  <completion_date type="Actual">April 14, 2017</completion_date>
  <primary_completion_date type="Actual">April 14, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5</time_frame>
    <description>The Plasma Concentration (Cmax) is defined as maximum observed plasma concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax)</measure>
    <time_frame>Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5</time_frame>
    <description>The Tmax is defined as actual sampling time to reach maximum observed plasma concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration Time (AUC [0-Last])</measure>
    <time_frame>Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5</time_frame>
    <description>AUC last is area under the plasma concentration-time curve from time zero to last quantifiable concentration time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])</measure>
    <time_frame>Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5</time_frame>
    <description>The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Terminal Elimination Rate Constant (Lambda [z])</measure>
    <time_frame>Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5</time_frame>
    <description>Lambda (z) is defined as apparent terminal elimination rate constant, determined by linear regression using the terminal log-linear phase of the log transformed concentration versus time curve.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Terminal Elimination Half-life (t1/2)</measure>
    <time_frame>Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5</time_frame>
    <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs)</measure>
    <time_frame>Up to follow-up (within 10 to 14 days after last dose)</time_frame>
    <description>Safety and Tolerability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Taste Questionnaire Assessment</measure>
    <time_frame>Day 1</time_frame>
    <description>A taste questionnaire will be completed by the participants of Panel 2, group 7 within 5 to 15 minutes after intake of the FDC tablet (Treatment E) to evaluate the taste of the oral FDC tablet formulation under fasted conditions. The Taste questionnaire consists of 4 parts (sweetness, bitterness, flavour and overall); each parts is scored on 4 points , i.e. none, weak, moderate and strong.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swallowability Assessment</measure>
    <time_frame>Day 1</time_frame>
    <description>Swallowability will be assessed in participants of Panel 2 group 7 on a scale of 1-7; how difficult/easy was it to swallow this tablet. In the scale 0=very difficult and 7=very easy.</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Panel 1: Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment A (JNJ-63623872 600 milligram (mg) (2*300 mg) oral tablets [reference]) followed by Treatment B (JNJ- 63623872 600 mg (2*300 mg) concept oral tablet formulation 1 (test 1) and then Treatment C (JNJ-63623872 600 mg (2*300 mg) concept oral tablet formulation 2 (test 2). Each treatment period will be separated 7 days washout period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel 1: Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in Group 2 will receive Treatment A followed by Treatment C and then Treatment B with a washout period of minimum 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel 1: Group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in Group 3 will receive Treatment B followed by Treatment A and then Treatment C with a washout period of minimum 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel 1: Group 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in Group 4 will receive Treatment B followed by Treatment C and then Treatment A with a washout period of minimum 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel 1: Group 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in Group 5 will receive Treatment C followed by Treatment A and then Treatment B with a washout period of minimum 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel 1: Group 6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in Group 6 will receive Treatment C followed by Treatment B and then Treatment A with a washout period of minimum 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel 2: Group 7</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in Group 7 will receive Treatment D [JNJ-63623872/37.5 mg Oseltamivir oral fixed dose combination (FDC) tablet concept formulation (test 3)] followed by Treatment E (JNJ-63623872 600 mg, administered as 2*300 mg and Oseltamivir 75 mg, administered as 1*75 mg). Both treatment periods will be separated with a minimum of 7 days washout period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel 2: Group 8</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in Group 8 will receive Treatment E followed by Treatment D with a washout period of minimum 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-63623872</intervention_name>
    <description>Participants will receive JNJ-63623872 600 mg (2*300 mg) oral tablets in Panel 1 and 2 under Fasted conditions.</description>
    <arm_group_label>Panel 1: Group 1</arm_group_label>
    <arm_group_label>Panel 1: Group 2</arm_group_label>
    <arm_group_label>Panel 1: Group 3</arm_group_label>
    <arm_group_label>Panel 1: Group 4</arm_group_label>
    <arm_group_label>Panel 1: Group 5</arm_group_label>
    <arm_group_label>Panel 1: Group 6</arm_group_label>
    <arm_group_label>Panel 2: Group 7</arm_group_label>
    <arm_group_label>Panel 2: Group 8</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oseltamivir</intervention_name>
    <description>Participants will receive Oseltamivir 75 mg (1*75 mg) oral capsule (reference) in Treatment D of Panel 2 and Oseltamivir 75 mg administered as JNJ-63623872/37.5 mg Oseltamivir oral FDC tablet concept formulation (test 3) in Treatment E of Panel 2.</description>
    <arm_group_label>Panel 2: Group 7</arm_group_label>
    <arm_group_label>Panel 2: Group 8</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A female participant must have a negative serum beta-human chorionic gonadotropin&#xD;
             pregnancy test at screening and on Day -1 in each treatment period&#xD;
&#xD;
          -  Contraceptive use by men or women should be consistent with local regulations&#xD;
             regarding the use of contraceptive methods for participant participating in clinical&#xD;
             studies&#xD;
&#xD;
          -  A female participant must agree not to donate eggs (ova, oocytes) for the purposes of&#xD;
             assisted reproduction during the study and for at least 90 days after receiving the&#xD;
             last dose of study drug&#xD;
&#xD;
          -  Participant must have a body mass index (BMI), weight kilogram per height square meter&#xD;
             square [kg]/height^2 [m]^2) between 18.0 and 30.0 kilogram per meter square (kg/m^2)&#xD;
             (extremes included) at screening. The minimum weight will be 50.0 kilogram (kg)&#xD;
&#xD;
          -  Participant must have a blood pressure (supine after at least 5 minutes rest) between&#xD;
             90 and 140 millimeters of mercury (mmHg) systolic, inclusive, and no higher than 90&#xD;
             mmHg diastolic at screening&#xD;
&#xD;
          -  Participant must be non-smoker for at least 3 months prior to screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant has history or current clinically significant medical illness including&#xD;
             (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic&#xD;
             disease, coagulation disorders, lipid abnormalities, significant pulmonary disease,&#xD;
             diabetes mellitus, hepatic or renal insufficiency, gastrointestinal disease, thyroid&#xD;
             disease, neurologic or psychiatric disease, infection, or any other illness that the&#xD;
             Investigator considers should exclude the participant or that could interfere with the&#xD;
             interpretation of the study results&#xD;
&#xD;
          -  Participant with a past history of heart arrhythmias (extrasystoli, tachycardia at&#xD;
             rest), or history of risk factors for Torsade de Pointes syndrome (eg, hypokalemia,&#xD;
             family history of long QT Syndrome)&#xD;
&#xD;
          -  Participant with any history of clinically significant skin disease such as, but not&#xD;
             limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria&#xD;
&#xD;
          -  Participant has known allergy to heparin or history of heparin induced&#xD;
             thrombocytopenia&#xD;
&#xD;
          -  Participant has donated blood or blood products or had substantial loss of blood (more&#xD;
             than 500 milliliter (mL) within 3 months before the first administration of study drug&#xD;
             or intention to donate blood or blood products during the study&#xD;
&#xD;
          -  A woman who is pregnant, or breast-feeding, or planning to become pregnant during this&#xD;
             study, or a woman of childbearing potential who is unwilling to use acceptable methods&#xD;
             of contraception&#xD;
&#xD;
          -  Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C virus&#xD;
             (HCV) antibody positive, or other clinically active liver disease, or tests positive&#xD;
             for HBsAg or anti-HCV at screening&#xD;
&#xD;
          -  Participant has a history of human immunodeficiency virus type 1 (HIV-1) or HIV-2&#xD;
             infection, or tests positive for HIV-1 or -2 at screening&#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>
  <overall_official>
    <last_name>Janssen-Cilag International NV Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen-Cilag International NV</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SGS Life Science Services</name>
      <address>
        <city>Antwerp</city>
        <zip>2060</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>May 24, 2017</last_update_submitted>
  <last_update_submitted_qc>May 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2017</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>Oseltamivir</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/NCT03023852
org study id: CR108252
secondary id: 63623872FLZ1011
secondary id: 2016-004504-62
nct id: NCT03023852
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the rate and extent of absorption of JNJ63623872
      following administration of a single oral dose of 2*300 milligram (mg) given as 2 concept
      single agent tablet formulations compared to the administration of 2*300 mg JNJ63623872
      reference tablets, under fasted conditions in healthy adult participants and to assess the
      rate and extent of absorption of JNJ63623872 and oseltamivir following administration of a
      single oral dose of 2*300 mg/37.5 mg JNJ63623872/ oseltamivir given as a concept fixed dose
      combination (FDC) tablet formulation compared to the coadministration of 2*300 mg JNJ63623872
      tablets (reference formulation) and 1*75 mg oseltamivir capsule, under fasted conditions in
      healthy adult participants.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5
description: The Plasma Concentration (Cmax) is defined as maximum observed plasma concentration.
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
time frame: Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5
description: The Tmax is defined as actual sampling time to reach maximum observed plasma concentration.
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration Time (AUC [0-Last])
time frame: Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5
description: AUC last is area under the plasma concentration-time curve from time zero to last quantifiable concentration time.
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
time frame: Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5
description: The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
measure: Apparent Terminal Elimination Rate Constant (Lambda [z])
time frame: Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5
description: Lambda (z) is defined as apparent terminal elimination rate constant, determined by linear regression using the terminal log-linear phase of the log transformed concentration versus time curve.
measure: Apparent Terminal Elimination Half-life (t1/2)
time frame: Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5
description: Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
measure: Number of Participants With Adverse Events (AEs)
time frame: Up to follow-up (within 10 to 14 days after last dose)
description: Safety and Tolerability
measure: Taste Questionnaire Assessment
time frame: Day 1
description: A taste questionnaire will be completed by the participants of Panel 2, group 7 within 5 to 15 minutes after intake of the FDC tablet (Treatment E) to evaluate the taste of the oral FDC tablet formulation under fasted conditions. The Taste questionnaire consists of 4 parts (sweetness, bitterness, flavour and overall); each parts is scored on 4 points , i.e. none, weak, moderate and strong.
measure: Swallowability Assessment
time frame: Day 1
description: Swallowability will be assessed in participants of Panel 2 group 7 on a scale of 1-7; how difficult/easy was it to swallow this tablet. In the scale 0=very difficult and 7=very easy.
arm group label: Panel 1: Group 1
arm group type: Experimental
description: Participants will receive Treatment A (JNJ-63623872 600 milligram (mg) (2*300 mg) oral tablets [reference]) followed by Treatment B (JNJ- 63623872 600 mg (2*300 mg) concept oral tablet formulation 1 (test 1) and then Treatment C (JNJ-63623872 600 mg (2*300 mg) concept oral tablet formulation 2 (test 2). Each treatment period will be separated 7 days washout period.
arm group label: Panel 1: Group 2
arm group type: Experimental
description: Participants in Group 2 will receive Treatment A followed by Treatment C and then Treatment B with a washout period of minimum 7 days.
arm group label: Panel 1: Group 3
arm group type: Experimental
description: Participants in Group 3 will receive Treatment B followed by Treatment A and then Treatment C with a washout period of minimum 7 days.
arm group label: Panel 1: Group 4
arm group type: Experimental
description: Participants in Group 4 will receive Treatment B followed by Treatment C and then Treatment A with a washout period of minimum 7 days.
arm group label: Panel 1: Group 5
arm group type: Experimental
description: Participants in Group 5 will receive Treatment C followed by Treatment A and then Treatment B with a washout period of minimum 7 days.
arm group label: Panel 1: Group 6
arm group type: Experimental
description: Participants in Group 6 will receive Treatment C followed by Treatment B and then Treatment A with a washout period of minimum 7 days.
arm group label: Panel 2: Group 7
arm group type: Experimental
description: Participants in Group 7 will receive Treatment D [JNJ-63623872/37.5 mg Oseltamivir oral fixed dose combination (FDC) tablet concept formulation (test 3)] followed by Treatment E (JNJ-63623872 600 mg, administered as 2*300 mg and Oseltamivir 75 mg, administered as 1*75 mg). Both treatment periods will be separated with a minimum of 7 days washout period.
arm group label: Panel 2: Group 8
arm group type: Experimental
description: Participants in Group 8 will receive Treatment E followed by Treatment D with a washout period of minimum 7 days.
intervention type: Drug
intervention name: JNJ-63623872
description: Participants will receive JNJ-63623872 600 mg (2*300 mg) oral tablets in Panel 1 and 2 under Fasted conditions.
arm group label: Panel 1: Group 1
arm group label: Panel 1: Group 2
arm group label: Panel 1: Group 3
arm group label: Panel 1: Group 4
arm group label: Panel 1: Group 5
arm group label: Panel 1: Group 6
arm group label: Panel 2: Group 7
arm group label: Panel 2: Group 8
intervention type: Drug
intervention name: Oseltamivir
description: Participants will receive Oseltamivir 75 mg (1*75 mg) oral capsule (reference) in Treatment D of Panel 2 and Oseltamivir 75 mg administered as JNJ-63623872/37.5 mg Oseltamivir oral FDC tablet concept formulation (test 3) in Treatment E of Panel 2.
arm group label: Panel 2: Group 7
arm group label: Panel 2: Group 8
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janssen-Cilag International NV Clinical Trial
role: Study Director
affiliation: Janssen-Cilag International NV
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Oseltamivir