0 Bedömningar
ID

36009

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 Predose Drug Screening/Alcohol Breath Test form. It has to be filled in for all Sessions each on Day 1 and for screening.

Nyckelord

Versioner (1)
  1. 2019-04-09 2019-04-09 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

9 april 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

  • Senaste
  • Äldsta
  • Önskad
  • Senaste
    • Senaste
    • Äldsta
    • Önskad

    Inga kommentarer

    Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

    Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

    Engelsk

    Predose Drug Screening/Alcohol Breath Test

    1 Formulär  
    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 type
    Beskrivning

    Visit type

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0545082
    Visit Date
    Beskrivning

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    Drug Screening
    Beskrivning

    Drug Screening

    Alias
    UMLS CUI-1
    C0373483
    Exact time of urine sampling
    Beskrivning

    00:00-23:59

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0040223
    Exact time of blood sampling
    Beskrivning

    00:00-23:59

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0040223
    Were there any contra-indicated drugs detected?
    Beskrivning

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

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1511790
    UMLS CUI [1,2]
    C1444657
    UMLS CUI [1,3]
    C1254351
    Type of drug
    Beskrivning

    Type of drug

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0457591
    Comment
    Beskrivning

    Comment

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0947611
    Alcohol breath test
    Beskrivning

    Alcohol breath test

    Alias
    UMLS CUI-1
    C0202306
    Exact time of test
    Beskrivning

    00:00-23:59

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C0429928
    Alcohol breath test, result
    Beskrivning

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

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0202306
    UMLS CUI [1,2]
    C1274040
    Tillbaka till toppen

    Similar models

    Predose Drug Screening/Alcohol Breath Test

    1 Formulär
    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])
    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)
    Tillbaka till toppen 

    Hjälp

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial