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ID

36906

Description

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the Pharmacokinetic sampling form. It has to befilled in for Day 1, Day 6, Day 12 and Day 19.

Mots-clés

Versions (2)
  1. 02/09/2017 02/09/2017 -
  2. 21/06/2019 21/06/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

21 juin 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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    Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

    Anglais

    PK Sampling

    1 Formulaires  
    1. StudyEvent: ODM
      1. PK Sampling
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject number
    Description

    Subject number

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Study Week
    Description

    Study Week

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0008972 (Clinical Research)
    UMLS CUI [1,2]
    C0439230 (week)
    SNOMED
    258705008
    Study Day
    Description

    Study Day

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2826182 (Study Day)
    PK SAMPLING
    Description

    PK SAMPLING

    Alias
    UMLS CUI-1
    C0022877 (Laboratory)
    SNOMED
    261904005
    LOINC
    MTHU029808
    Time relative to start of dose
    Description

    Time relative to start of dose

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0439564 (Relative time)
    SNOMED
    118578006
    LOINC
    LP21276-8
    UMLS CUI [1,2]
    C1301880 (Start time)
    SNOMED
    398201009
    LOINC
    LP102339-1
    UMLS CUI [1,3]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    Date
    Description

    day month year The date has to be filled in for Pre-dose, +8 hrs and +10 hrs. If required you can also fill in the date for the other times.

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0808070 (Start Date)
    UMLS CUI [1,2]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    Actual time
    Description

    00:00-23:59

    Type de données

    time

    Alias
    UMLS CUI [1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Sample taken
    Description

    Sample taken

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0200345 (Specimen Collection)
    SNOMED
    17636008
    Comments
    Description

    Comments

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Retour au début de la page

    Similar models

    PK Sampling

    1 Formulaires
    1. StudyEvent: ODM
      1. PK Sampling
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Item
    Study Week
    integer
    C0008972 (UMLS CUI [1,1])
    C0439230 (UMLS CUI [1,2])
    Study Week
    Code List
    Study Week
    CL Item
    Week 1 (1)
    CL Item
    Week 2 (2)
    CL Item
    Week 3 (3)
    Item
    Study Day
    integer
    C2826182 (UMLS CUI [1])
    Study Day
    Code List
    Study Day
    CL Item
    Day 1 (1)
    CL Item
    Day 6 (2)
    CL Item
    Day 12 (3)
    CL Item
    Day 19 (4)
    Item Group
    PK SAMPLING
    C0022877 (UMLS CUI-1)
    Item
    Time relative to start of dose
    integer
    C0439564 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    C0178602 (UMLS CUI [1,3])
    Time relative to start of dose
    Code List
    Time relative to start of dose
    CL Item
    Pre-dose (1)
    CL Item
    +0,25 hr (2)
    CL Item
    +0,5 hr (3)
    CL Item
    +0,75 hr (4)
    CL Item
    +1 hr (5)
    CL Item
    +2 hrs (6)
    CL Item
    +3 hrs (7)
    CL Item
    +4 hrs (8)
    CL Item
    +6 hrs (9)
    CL Item
    +8 hrs (10)
    CL Item
    +10 hrs (11)
    CL Item
    +12 hrs (12)
    CL Item
    +14 hrs (13)
    CL Item
    +16 hrs (14)
    CL Item
    +24 hrs (15)
    Date of start dose
    Item
    Date
    date
    C0808070 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    Actual time
    Item
    Actual time
    time
    C0040223 (UMLS CUI [1])
    Item
    Sample taken
    text
    C0200345 (UMLS CUI [1])
    Sample taken
    Code List
    Sample taken
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Retour au début de la page 

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