ID

25710

Description

Study ID: 101468/197 Clinical Study ID: SKF-101468/197 Study Title:An open study to compare the PK and tolerability of ropinirole administered as 5 different new formulations with the standard, marketed formulation in healthy 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 : Restless Legs Syndrome

Keywords

Versions (1)
  1. 9/12/17 9/12/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 12, 2017

DOI

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License

Creative Commons BY-NC 3.0
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visit period 1,2,3 & 4 meals and fluids day 1 PK and tolerability of ropinirole as 5 new formulations 101468/197

English

visit period 1,2,3 & 4 meals and fluids day 1 PK and tolerability of ropinirole as 5 new formulations 101468/197

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Focus Panel ID
Description

focus panel

Data type

integer

Alias
UMLS CUI [1]
C3846158
Patient No
Description

patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Date
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Number of Visit
Description

visit number

Data type

text

Alias
UMLS CUI [1]
C1549755
Treatment
Description

treatment

Data type

text

Alias
UMLS CUI [1]
C0087111
Meals and Fluids
Description

Meals and Fluids

Alias
UMLS CUI-1
C0518009
Was meal in take according to the protocol?
Description

If no, please specify

Data type

boolean

Alias
UMLS CUI [1,1]
C0458244
UMLS CUI [1,2]
C0525058
Meals and Fluids: Day 1
Description

Meals and Fluids: Day 1

Alias
UMLS CUI-1
C0518009
Scheduled time
Description

scheduled time

Data type

text

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1301732
Scheduled time followed?
Description

time protocol compliant

Data type

boolean

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0525058
Comments
Description

comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Meals and Fluids: Day 2
Description

Meals and Fluids: Day 2

Alias
UMLS CUI-1
C0518009
Scheduled time
Description

scheduled time

Data type

text

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1301732
Scheduled time followed?
Description

time protocol compliant

Data type

boolean

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0525058
Comments
Description

comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Comments
Description

Comments

Alias
UMLS CUI-1
C0947611
Comments
Description

comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Initials
Description

Initials

Alias
UMLS CUI-1
C2986440
Initials
Description

initials

Data type

text

Alias
UMLS CUI [1]
C2986440
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Similar models

visit period 1,2,3 & 4 meals and fluids day 1 PK and tolerability of ropinirole as 5 new formulations 101468/197

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
focus panel
Item
Focus Panel ID
integer
C3846158 (UMLS CUI [1])
patient number
Item
Patient No
integer
C1830427 (UMLS CUI [1])
date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Number of Visit
text
C1549755 (UMLS CUI [1])
visit number
Code List
Number of Visit
CL Item
Period 1 Day 1 (Period 1 Day 1)
CL Item
Period 2 Day 1 (Period 2 Day 1)
CL Item
Period 3 Day 1 (Period 3 Day 1)
CL Item
Period 4 Day 1 (Period 4 Day 1)
treatment
Item
Treatment
text
C0087111 (UMLS CUI [1])
Item Group
Meals and Fluids
C0518009 (UMLS CUI-1)
meal intake according to the protocol
Item
Was meal in take according to the protocol?
boolean
C0458244 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
Item Group
Meals and Fluids: Day 1
C0518009 (UMLS CUI-1)
Item
Scheduled time
text
C0040223 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
scheduled time
Code List
Scheduled time
CL Item
+4: 15 h / lunch (+4: 15 h / lunch)
CL Item
+9:00 h / dinner (+9:00 h / dinner)
CL Item
+ 12:15 h / snack (+ 12:15 h / snack)
time protocol compliant
Item
Scheduled time followed?
boolean
C0040223 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Meals and Fluids: Day 2
C0518009 (UMLS CUI-1)
Item
Scheduled time
text
C0040223 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
scheduled time
Code List
Scheduled time
CL Item
breakfast (breakfast)
CL Item
lunch (lunch)
CL Item
dinner (dinner)
time protocol compliant
Item
Scheduled time followed?
boolean
C0040223 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Comments
C0947611 (UMLS CUI-1)
comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Initials
C2986440 (UMLS CUI-1)
initials
Item
Initials
text
C2986440 (UMLS CUI [1])
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