<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/NCT02981290</url>
  </required_header>
  <id_info>
    <org_study_id>WP21980</org_study_id>
    <nct_id>NCT02981290</nct_id>
  </id_info>
  <brief_title>Study to Compare the Pharmacokinetics of Mycophenolate Mofetil Metabolites From Four Tablet Formulations in Healthy Participants</brief_title>
  <official_title>A Randomized, Open Label, Four-way Crossover Study to Compare the Pharmacokinetics of Mycophenolate Mofetil Metabolites From Four Tablet Formulations in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single center, randomized, open label, 4-treatment, 4-period, 4-sequence, 4-way&#xD;
      crossover study to compare the pharmacokinetics of mycophenolate mofetil (MMF) metabolites&#xD;
      from 4 tablet formulations in healthy participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2008</start_date>
  <completion_date type="Actual">October 2008</completion_date>
  <primary_completion_date type="Actual">October 2008</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>Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of MPA</measure>
    <time_frame>Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of MPA</measure>
    <time_frame>Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) of MPA</measure>
    <time_frame>Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax) of MPA</measure>
    <time_frame>Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Absorption Lag Time (Tlag) of MPA</measure>
    <time_frame>Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Terminal Half-Life (t1/2) of MPA</measure>
    <time_frame>Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Oral Clearance (CL/F) of MPA</measure>
    <time_frame>Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Apparent Oral Volume of Distribution (V/F) of MPA</measure>
    <time_frame>Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC (0-inf) of the Glucuronide Metabolite of MPA (MPAG)</measure>
    <time_frame>Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUClast of MPAG</measure>
    <time_frame>Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax of MPAG</measure>
    <time_frame>Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax of MPAG</measure>
    <time_frame>Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tlag of MPAG</measure>
    <time_frame>Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 of MPAG</measure>
    <time_frame>Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F of MPAG</measure>
    <time_frame>Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>V/F of MPAG</measure>
    <time_frame>Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Baseline up to 9 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Renodapt Then Mycept Then Cellmune Then CellCept</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Renodapt in first treatment period (each treatment period= 3 days) followed by Mycept in second treatment period then Cellmune in third treatment period and CellCept in fourth treatment period. A washout period of 7 days will be separating each treatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mycept Then CellCept Then Renodapt Then Cellmune</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Mycept in first treatment period (each treatment period= 3 days) followed by CellCept in second treatment period then Renodapt in third treatment period and Cellmune in fourth treatment period. A washout period of 7 days will be separating each treatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cellmune Then Renodapt Then CellCept Then Mycept</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Cellmune in first treatment period (each treatment period= 3 days) followed by Renodapt in second treatment period then CellCept in third treatment period and Mycept in fourth treatment period. A washout period of 7 days will be separating each treatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CellCept Then Cellmune Then Mycept Then Renodapt</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive CellCept in first treatment period (each treatment period= 3 days) followed by Cellmune in second treatment period then Mycept in third treatment period and Renodapt in fourth treatment period. A washout period of 7 days will be separating each treatment period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Renodapt</intervention_name>
    <description>Renodapt will be administered as 500 milligrams (mg) tablet orally on Day 1 in any treatment periods.</description>
    <arm_group_label>CellCept Then Cellmune Then Mycept Then Renodapt</arm_group_label>
    <arm_group_label>Cellmune Then Renodapt Then CellCept Then Mycept</arm_group_label>
    <arm_group_label>Mycept Then CellCept Then Renodapt Then Cellmune</arm_group_label>
    <arm_group_label>Renodapt Then Mycept Then Cellmune Then CellCept</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mycept</intervention_name>
    <description>Mycept will be administered as 500 mg tablet orally on Day 1 in any treatment periods.</description>
    <arm_group_label>CellCept Then Cellmune Then Mycept Then Renodapt</arm_group_label>
    <arm_group_label>Cellmune Then Renodapt Then CellCept Then Mycept</arm_group_label>
    <arm_group_label>Mycept Then CellCept Then Renodapt Then Cellmune</arm_group_label>
    <arm_group_label>Renodapt Then Mycept Then Cellmune Then CellCept</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cellmune</intervention_name>
    <description>Cellmune will be administered as 500 mg tablet orally on Day 1 in any treatment periods.</description>
    <arm_group_label>CellCept Then Cellmune Then Mycept Then Renodapt</arm_group_label>
    <arm_group_label>Cellmune Then Renodapt Then CellCept Then Mycept</arm_group_label>
    <arm_group_label>Mycept Then CellCept Then Renodapt Then Cellmune</arm_group_label>
    <arm_group_label>Renodapt Then Mycept Then Cellmune Then CellCept</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CellCept</intervention_name>
    <description>CellCept will be administered as 500 mg tablet orally on Day 1 in any treatment periods.</description>
    <arm_group_label>CellCept Then Cellmune Then Mycept Then Renodapt</arm_group_label>
    <arm_group_label>Cellmune Then Renodapt Then CellCept Then Mycept</arm_group_label>
    <arm_group_label>Mycept Then CellCept Then Renodapt Then Cellmune</arm_group_label>
    <arm_group_label>Renodapt Then Mycept Then Cellmune Then CellCept</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        A body mass index (BMI) between 18 and 32 kilogram per meter square (kg/m^2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any evidence of clinically significant allergic, renal, cardiac, bronchopulmonary,&#xD;
             vascular, gastro-intestinal, neurological, metabolic or immunodeficiency disorders,&#xD;
             cancer, hepatitis or cirrhosis&#xD;
&#xD;
          -  Any evidence of gall bladder surgery, surgery of the gastro-intestinal tract or any&#xD;
             other medical condition considered likely to affect drug absorption&#xD;
&#xD;
          -  Any major illness within 2 months prior to first dosing or febrile illness within 14&#xD;
             days prior to first dosing&#xD;
&#xD;
          -  Any known history of clinically significant allergic reactions or drug&#xD;
             hypersensitivity, especially hypersensitivity to MMF or mycophenolic acid (MPA)&#xD;
&#xD;
          -  Any other ongoing concomitant disease or condition that could interfere with, or the&#xD;
             treatment of which might interfere with, the conduct of the study, or that would, in&#xD;
             the opinion of the investigator, pose an unacceptable risk to the participants&#xD;
&#xD;
          -  Any prescribed or over-the-counter (OTC) medication, herbal medicine or dietary aid&#xD;
             taken within 2 weeks before the first study drug dosing or within six times the&#xD;
             elimination half-life of the medication before the first study drug dosing&#xD;
      </textblock>
    </criteria>
    <gender>Male</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>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Christchurch Clinical Studies Trust</name>
      <address>
        <city>Christchurch</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>New Zealand</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>December 1, 2016</last_update_submitted>
  <last_update_submitted_qc>December 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 5, 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>Mycophenolic Acid</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/NCT02981290
org study id: WP21980
nct id: NCT02981290
lead sponsor: 
has dmc: No
This is a single center, randomized, open label, 4-treatment, 4-period, 4-sequence, 4-way
      crossover study to compare the pharmacokinetics of mycophenolate mofetil (MMF) metabolites
      from 4 tablet formulations in healthy participants.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of MPA
time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of MPA
time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
measure: Maximum Observed Plasma Concentration (Cmax) of MPA
time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of MPA
time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
measure: Absorption Lag Time (Tlag) of MPA
time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
measure: Plasma Terminal Half-Life (t1/2) of MPA
time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
measure: Apparent Oral Clearance (CL/F) of MPA
time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
measure: Apparent Oral Volume of Distribution (V/F) of MPA
time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
measure: AUC (0-inf) of the Glucuronide Metabolite of MPA (MPAG)
time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
measure: AUClast of MPAG
time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
measure: Cmax of MPAG
time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
measure: Tmax of MPAG
time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
measure: Tlag of MPAG
time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
measure: t1/2 of MPAG
time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
measure: CL/F of MPAG
time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
measure: V/F of MPAG
time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
measure: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: Baseline up to 9 weeks
arm group label: Renodapt Then Mycept Then Cellmune Then CellCept
arm group type: Experimental
description: Participants will receive Renodapt in first treatment period (each treatment period= 3 days) followed by Mycept in second treatment period then Cellmune in third treatment period and CellCept in fourth treatment period. A washout period of 7 days will be separating each treatment period.
arm group label: Mycept Then CellCept Then Renodapt Then Cellmune
arm group type: Experimental
description: Participants will receive Mycept in first treatment period (each treatment period= 3 days) followed by CellCept in second treatment period then Renodapt in third treatment period and Cellmune in fourth treatment period. A washout period of 7 days will be separating each treatment period.
arm group label: Cellmune Then Renodapt Then CellCept Then Mycept
arm group type: Experimental
description: Participants will receive Cellmune in first treatment period (each treatment period= 3 days) followed by Renodapt in second treatment period then CellCept in third treatment period and Mycept in fourth treatment period. A washout period of 7 days will be separating each treatment period.
arm group label: CellCept Then Cellmune Then Mycept Then Renodapt
arm group type: Experimental
description: Participants will receive CellCept in first treatment period (each treatment period= 3 days) followed by Cellmune in second treatment period then Mycept in third treatment period and Renodapt in fourth treatment period. A washout period of 7 days will be separating each treatment period.
intervention type: Drug
intervention name: Renodapt
description: Renodapt will be administered as 500 milligrams (mg) tablet orally on Day 1 in any treatment periods.
arm group label: CellCept Then Cellmune Then Mycept Then Renodapt
arm group label: Cellmune Then Renodapt Then CellCept Then Mycept
arm group label: Mycept Then CellCept Then Renodapt Then Cellmune
arm group label: Renodapt Then Mycept Then Cellmune Then CellCept
intervention type: Drug
intervention name: Mycept
description: Mycept will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
arm group label: CellCept Then Cellmune Then Mycept Then Renodapt
arm group label: Cellmune Then Renodapt Then CellCept Then Mycept
arm group label: Mycept Then CellCept Then Renodapt Then Cellmune
arm group label: Renodapt Then Mycept Then Cellmune Then CellCept
intervention type: Drug
intervention name: Cellmune
description: Cellmune will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
arm group label: CellCept Then Cellmune Then Mycept Then Renodapt
arm group label: Cellmune Then Renodapt Then CellCept Then Mycept
arm group label: Mycept Then CellCept Then Renodapt Then Cellmune
arm group label: Renodapt Then Mycept Then Cellmune Then CellCept
intervention type: Drug
intervention name: CellCept
description: CellCept will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
arm group label: CellCept Then Cellmune Then Mycept Then Renodapt
arm group label: Cellmune Then Renodapt Then CellCept Then Mycept
arm group label: Mycept Then CellCept Then Renodapt Then Cellmune
arm group label: Renodapt Then Mycept Then Cellmune Then CellCept
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
country: New Zealand
responsible party type: Sponsor
mesh term: Mycophenolic Acid
sharing ipd: No