ID

43569

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 (3)
  1. 9/11/17 9/11/17 -
  2. 9/12/17 9/12/17 -
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

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

English

visit period 1,2,3 & 4 plasma drug assay 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
Date and Time
Description

Date and Time

Alias
UMLS CUI-1
C1264639
Actual date and time of dose
Description

date and time of dose

Data type

datetime

Alias
UMLS CUI [1]
C1264639
UMLS CUI [2]
C3469597
plasma assay sample
Description

plasma assay sample

Alias
UMLS CUI-1
C0444263
UMLS CUI-3
C0013227
UMLS CUI-4
C0683150
Time relative to dosing
Description

time relative to dosing

Data type

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0304229
Date
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Time
Description

time

Data type

time

Alias
UMLS CUI [1]
C0040223
Comment
Description

comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Initials
Description

initials

Data type

text

Alias
UMLS CUI [1]
C2986440
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Similar models

visit period 1,2,3 & 4 plasma drug assay 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 1-2 (Period 1 Day 1-2)
CL Item
Period 2 Day 1-2 (Period 2 Day 1-2)
CL Item
Period 3 Day 1-2 (Period 3 Day 1-2)
CL Item
Period 4 Day 1-2 (Period 4 Day 1-2)
treatment
Item
Treatment
text
C0087111 (UMLS CUI [1])
Item Group
Date and Time
C1264639 (UMLS CUI-1)
date and time of dose
Item
Actual date and time of dose
datetime
C1264639 (UMLS CUI [1])
C3469597 (UMLS CUI [2])
Item Group
plasma assay sample
C0444263 (UMLS CUI-1)
C0013227 (UMLS CUI-3)
C0683150 (UMLS CUI-4)
Item
Time relative to dosing
text
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
time relative to dosing
Code List
Time relative to dosing
CL Item
+0:15h (+0:15h)
CL Item
+0:30h (+0:30h)
CL Item
+0:45h (+0:45h)
CL Item
+1:00h (+ 1:00h)
CL Item
+2:00h (+ 2:00h)
CL Item
+3:00h (+ 3:00h)
CL Item
+4:00h (+ 4:00h)
CL Item
+6:00h (+ 6:00h)
CL Item
+8:00h (+ 8:00h)
CL Item
+10:00h (+ 10:00h)
CL Item
+12:00h (+ 12:00h)
CL Item
+14:00h (+ 14:00h)
CL Item
+16:00h (+ 16:00h)
CL Item
+18:00h (+ 18:00h)
CL Item
+20:00h (+ 20:00h)
CL Item
+22:00h (+ 22:00h)
CL Item
+24:00h (+ 24:00h)
CL Item
+28:00h (+ 28:00h)
CL Item
+32:00h (+ 32:00h)
CL Item
+36:00h (+ 36:00h)
date
Item
Date
date
C0011008 (UMLS CUI [1])
time
Item
Time
time
C0040223 (UMLS CUI [1])
comment
Item
Comment
text
C0947611 (UMLS CUI [1])
initials
Item
Initials
text
C2986440 (UMLS CUI [1])
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