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36091

Beschreibung

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 Drug Screening and Alcohol Breath Test for screening form. It has to be filled in for screening.

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  1. 15.04.19 15.04.19 -
  2. 15.04.19 15.04.19 -
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GlaxoSmithKline

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15. 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

    Englisch

    Drug Screening and Alcohol Breath Test for screening

    1 Formulare  
    Administrative data
    Beschreibung

    Administrative data

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

    Subject No.:

    Datentyp

    text

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

    Panel ID

    Datentyp

    text

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

    day month year

    Datentyp

    date

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

    Drug Screening

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

    00:00-23:59

    Datentyp

    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
    Beschreibung

    00:00-23:59

    Datentyp

    time

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

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

    Datentyp

    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
    Beschreibung

    Type of drug

    Datentyp

    text

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

    Comment

    Datentyp

    text

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

    Alcohol breath test

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

    00:00-23:59

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0202306 (Ethanol measurement, breath)
    SNOMED
    1820004
    UMLS CUI [1,2]
    C0429928 (Test time)
    SNOMED
    252127002
    Result of Alcohol breath test
    Beschreibung

    Alcohol breath test result, tick one If POSITIVE, do not include the subject in the study.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0202306 (Ethanol measurement, breath)
    SNOMED
    1820004
    UMLS CUI [1,2]
    C1274040 (Result)
    SNOMED
    394617004
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Drug Screening and Alcohol Breath Test for screening

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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])
    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])
    Blodd sampling time
    Item
    Exact time of blood sampling
    time
    C0040223 (UMLS CUI [1,1])
    C0005834 (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
    C0202306 (UMLS CUI [1,1])
    C0429928 (UMLS CUI [1,2])
    Item
    Result of Alcohol breath test
    text
    C0202306 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Result of Alcohol breath test
    Code List
    Result of Alcohol breath test
    CL Item
    Positive (P)
    CL Item
    Negative (N)
    Zum Seitenanfang zurückkehren 

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