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ID

36009

Beschrijving

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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 a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Predose Drug Screening/Alcohol Breath Test form. It has to be filled in for all Sessions each on Day 1 and for screening.

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Versies (1)
  1. 09-04-19 09-04-19 -
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GlaxoSmithKline

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9 april 2019

DOI

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Creative Commons BY-NC 3.0
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    Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

    Engels

    Predose Drug Screening/Alcohol Breath Test

    1 Formulieren  
    Administrative data
    Beschrijving

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject No.
    Beschrijving

    Subject No.

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Panel ID
    Beschrijving

    Panel ID

    Datatype

    text

    Alias
    UMLS CUI [1]
    C3846158 (Other Coding)
    LOINC
    LA4728-7
    Visit type
    Beschrijving

    Visit type

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0545082 (Visit)
    Visit Date
    Beschrijving

    day month year

    Datatype

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Drug Screening
    Beschrijving

    Drug Screening

    Alias
    UMLS CUI-1
    C0373483 (Drug screen (procedure))
    Exact time of urine sampling
    Beschrijving

    00:00-23:59

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0042014 (Urinalysis)
    SNOMED
    167217005
    LOINC
    LP32744-2
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Exact time of blood sampling
    Beschrijving

    00:00-23:59

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Were there any contra-indicated drugs detected?
    Beschrijving

    If YES, please record all the relevant contra-indicated drugs below.

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1511790 (Detection)
    UMLS CUI [1,2]
    C1444657 (Contraindicated)
    SNOMED
    410536001
    LOINC
    LA4216-3
    UMLS CUI [1,3]
    C1254351 (Pharmacologic Substance)
    LOINC
    LP172750-4
    Type of drug
    Beschrijving

    Type of drug

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0457591 (Type of drug)
    SNOMED
    229753003
    Comment
    Beschrijving

    Comment

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Alcohol breath test
    Beschrijving

    Alcohol breath test

    Alias
    UMLS CUI-1
    C0202306 (Ethanol measurement, breath)
    SNOMED
    1820004
    Exact time of test
    Beschrijving

    00:00-23:59

    Datatype

    time

    Alias
    UMLS CUI [1]
    C0429928 (Test time)
    SNOMED
    252127002
    Alcohol breath test, result
    Beschrijving

    If POSITIVE, do not include the subject in the study.

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0202306 (Ethanol measurement, breath)
    SNOMED
    1820004
    UMLS CUI [1,2]
    C1274040 (Result)
    SNOMED
    394617004
    Terug naar het begin van de pagina

    Similar models

    Predose Drug Screening/Alcohol Breath Test

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject No.
    Item
    Subject No.
    text
    C2348585 (UMLS CUI [1])
    Panel ID
    Item
    Panel ID
    text
    C3846158 (UMLS CUI [1])
    Item
    Visit type
    integer
    C0545082 (UMLS CUI [1])
    Visit type
    Code List
    Visit type
    CL Item
    Screening (1)
    CL Item
    Session 1 day 1 (2)
    CL Item
    Session 2 day 1  (3)
    CL Item
    Session 3 day 1 (4)
    CL Item
    Session 4 day 1 (5)
    CL Item
    Session 5 day 1 (6)
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Drug Screening
    C0373483 (UMLS CUI-1)
    Urine sampling time
    Item
    Exact time of urine sampling
    time
    C0042014 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Blood sampling time
    Item
    Exact time of blood sampling
    time
    C0005834 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Were there any contra-indicated drugs detected?
    text
    C1511790 (UMLS CUI [1,1])
    C1444657 (UMLS CUI [1,2])
    C1254351 (UMLS CUI [1,3])
    Contra-indicated drugs detected
    Code List
    Were there any contra-indicated drugs detected?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Type of drug
    Item
    Type of drug
    text
    C0457591 (UMLS CUI [1])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Alcohol breath test
    C0202306 (UMLS CUI-1)
    Time of test
    Item
    Exact time of test
    time
    C0429928 (UMLS CUI [1])
    Item
    Alcohol breath test, result
    text
    C0202306 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Alcohol breath test, result
    Code List
    Alcohol breath test, result
    CL Item
    Negative (N)
    CL Item
    Positive (P)
    Terug naar het begin van de pagina 

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