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ID

26110

Description

Study ID: 101468/219 Clinical Study ID: 101468/219 Study Title:An open label, randomised, five-way crossover single-dose pharmacokinetic study to assess dosage strength equivalence of ropinirole CR in healthy male and female volunteers 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: Requip Study Indication : Parkinson Disease Documentation part: Prior Medication

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Versions (1)
  1. 09/10/2017 09/10/2017 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

9 octobre 2017

DOI

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Licence

Creative Commons BY-NC 3.0
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    Dose strength equivalence of ropinirole CR in healthy adults Prior Medication 101468/219

    Anglais

    Prior Medication Dose strength equivalence of ropinirole CR in healthy adults 101468/219

    1 Formulaires  
    Prior Medication
    Description

    Prior Medication

    Alias
    UMLS CUI-1
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI-2
    C2826257 (Prior Medication Usage)
    UMLS CUI-3
    C0244821 (ropinirole)
    SNOMED
    108473005
    Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
    Description

    If ’YES’, please record the medications below. NB: Any medications Metabolised by CYPIA2 must be kept constant throughout the study.

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    drug name
    Description

    Trade Name Preferred

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    Single Dose/Unit
    Description

    dose per unit

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C3174092 (Medication dose)
    LOINC
    LP116765-1
    Frequency of this Dose
    Description

    medication frequency

    Type de données

    text

    Alias
    UMLS CUI [1]
    C3476109 (Medication frequency)
    LOINC
    LP149758-7
    Route
    Description

    drug application route

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0013153 (Drug Administration Routes)
    SNOMED
    410675002
    LOINC
    LP40261-7
    Indication
    Description

    medication indication

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C3146298 (Indication)
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Duration
    Description

    duration of medication

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0449238 (Duration (temporal concept))
    SNOMED
    762636008
    LOINC
    LP14744-4
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    End Date
    Description

    end date of medication

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Continuing at end of study?
    Description

    continuing medication

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C2826666 (Concomitant Medication Ongoing)
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Retour au début de la page

    Similar models

    Prior Medication Dose strength equivalence of ropinirole CR in healthy adults 101468/219

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Prior Medication
    C0013227 (UMLS CUI-1)
    C2826257 (UMLS CUI-2)
    C0244821 (UMLS CUI-3)
    medication
    Item
    Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
    boolean
    C0013227 (UMLS CUI [1])
    drug name
    Item
    drug name
    text
    C2360065 (UMLS CUI [1])
    dose per unit
    Item
    Single Dose/Unit
    integer
    C3174092 (UMLS CUI [1])
    medication frequency
    Item
    Frequency of this Dose
    text
    C3476109 (UMLS CUI [1])
    drug application route
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    medication indication
    Item
    Indication
    text
    C3146298 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    duration of medication
    Item
    Duration
    text
    C0449238 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    end date of medication
    Item
    End Date
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    continuing medication
    Item
    Continuing at end of study?
    boolean
    C2826666 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Retour au début de la page 

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