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ID

36089

Beskrivning

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 prior medication form. It has to be filled in for screening.

Nyckelord

Versioner (3)
  1. 15-04-19 15-04-19 -
  2. 15-04-19 15-04-19 -
  3. 20-09-21 20-09-21 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

15 april 2019

DOI

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Licens

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

    Engelsk

    Prior Medication

    1 Formulär  
    1. StudyEvent: ODM
      1. Prior Medication
    Administrative data
    Beskrivning

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject No.
    Beskrivning

    Subject No.

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Panel ID
    Beskrivning

    Panel ID

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C3846158
    Visit Date
    Beskrivning

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    Prior Medication
    Beskrivning

    Prior Medication

    Alias
    UMLS CUI-1
    C2826257
    Has the subject taken any prescribed medication within 14 days prior to first dosing day or any OTC medicine within 7 days before the first study day?
    Beskrivning

    If 'YES', please record the medications below.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3166216
    UMLS CUI [2]
    C0013231
    DRUG NAME
    Beskrivning

    (Trade Name Preferred)

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2360065
    Single Dose/Unit (e.g.500 mg)
    Beskrivning

    Single Dose/Unit

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1960417
    Frequency of this Dose (e.g.BID, PR)
    Beskrivning

    Frequency of this Dose

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C3476109
    Route
    Beskrivning

    Route

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0013153
    Indication
    Beskrivning

    Indication

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C3146298
    UMLS CUI [1,2]
    C0013227
    Duration of therapy (e.g.6 years)
    Beskrivning

    Duration of therapy

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0444917
    End Date
    Beskrivning

    Day/Month/Year

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0806020
    Continuing at end of study?
    Beskrivning

    Continuing at end of study

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1553904
    UMLS CUI [1,2]
    C2983670
    Tillbaka till toppen

    Similar models

    Prior Medication

    1 Formulär
    1. StudyEvent: ODM
      1. Prior Medication
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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
    Prior Medication
    C2826257 (UMLS CUI-1)
    Prescribed or OTC medication
    Item
    Has the subject taken any prescribed medication within 14 days prior to first dosing day or any OTC medicine within 7 days before the first study day?
    boolean
    C3166216 (UMLS CUI [1])
    C0013231 (UMLS CUI [2])
    DRUG NAME
    Item
    DRUG NAME
    text
    C2360065 (UMLS CUI [1])
    Single Dose/Unit
    Item
    Single Dose/Unit (e.g.500 mg)
    text
    C1960417 (UMLS CUI [1])
    Frequency of this Dose
    Item
    Frequency of this Dose (e.g.BID, PR)
    text
    C3476109 (UMLS CUI [1])
    Route
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    Indication
    Item
    Indication
    text
    C3146298 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Duration of therapy
    Item
    Duration of therapy (e.g.6 years)
    text
    C0444917 (UMLS CUI [1])
    End Date
    Item
    End Date
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Continuing at end of study
    Item
    Continuing at end of study?
    boolean
    C1553904 (UMLS CUI [1,1])
    C2983670 (UMLS CUI [1,2])
    Tillbaka till toppen 

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