ID

36095

Description

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.

Keywords

  1. 4/15/19 4/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 15, 2019

DOI

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License

Creative Commons BY-NC 3.0

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

Predose Meal Recording

  1. StudyEvent: ODM
    1. Predose Meal Recording
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject No.
Description

Subject No.

Data type

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Description

Panel ID

Data type

text

Alias
UMLS CUI [1]
C3846158
Visit type
Description

Visit type

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Visit Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Meal Recording
Description

Meal Recording

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

Meal before dosing

Data type

text

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

Kind of meal

Data type

integer

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

00.00-23:59

Data type

time

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

00:00-23:59

Data type

time

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

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611

Similar models

Predose Meal Recording

  1. StudyEvent: ODM
    1. Predose Meal Recording
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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])
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])
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])

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