ID

36095

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 Meal Recording form. It has to be filled in for all sessions each for day 1.

Nyckelord

Versioner (1)
  1. 2019-04-15 2019-04-15 -
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

Predose Meal Recording

1 Formulär  
  1. StudyEvent: ODM
    1. Predose Meal Recording
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 [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Visit Date
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Meal Recording
Beskrivning

Meal Recording

Alias
UMLS CUI-1
C1998602
UMLS CUI-2
C0034869
Was the meal eaten before dosing?
Beskrivning

Meal before dosing

Datatyp

text

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C3469597
Kind of meal
Beskrivning

Kind of meal

Datatyp

integer

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0332307
Start time of eating meal
Beskrivning

00.00-23:59

Datatyp

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C3842710
Stop time of eating meal
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C3842710
Comments
Beskrivning

Comments

Datatyp

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Predose Meal Recording

1 Formulär
  1. StudyEvent: ODM
    1. Predose Meal Recording
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 [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Session 1 day 1 (1)
CL Item
Session 2 day 1 (2)
CL Item
Session 3 day 1 (3)
CL Item
Session 4 day 1 (4)
CL Item
Session 5 day 1 (5)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Meal Recording
C1998602 (UMLS CUI-1)
C0034869 (UMLS CUI-2)
Item
Was the meal eaten before dosing?
text
C1998602 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,3])
Meal before dosing
Code List
Was the meal eaten before dosing?
CL Item
Yes (Y)
CL Item
No (N)
Item
Kind of meal
integer
C1998602 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Kind of meal
Code List
Kind of meal
CL Item
standardised normal meal (1)
CL Item
high fat FDA meal (2)
Start time
Item
Start time of eating meal
time
C1301880 (UMLS CUI [1,1])
C3842710 (UMLS CUI [1,2])
Stop time
Item
Stop time of eating meal
time
C1522314 (UMLS CUI [1,1])
C3842710 (UMLS CUI [1,2])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Tillbaka till toppen 

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