ID

25713

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 (7)
  1. 8/31/17 8/31/17 -
  2. 8/31/17 8/31/17 -
  3. 8/31/17 8/31/17 -
  4. 9/4/17 9/4/17 -
  5. 9/4/17 9/4/17 -
  6. 9/4/17 9/4/17 -
  7. 9/12/17 9/12/17 -
Uploaded on

September 12, 2017

DOI

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License

Creative Commons BY-NC 3.0
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screening & final examination laboratory collections PK and tolerability of ropinirole as 5 new formulations 101468/197

English

screening & final examination laboratory collections 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

Only consider this item, if "Final Examination" above.

Data type

text

Alias
UMLS CUI [1]
C0087111
Initials
Description

initials

Data type

text

Alias
UMLS CUI [1]
C2986440
CLINICAL CHEMISTRY & HEMATOLOGY
Description

CLINICAL CHEMISTRY & HEMATOLOGY

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0018941
A blood sample has been taken for clinical chemistry and hematology (including Hepatitis B/C surface antigen, HIV tests and coagulation)?
Description

blood sample taken

Data type

text

Alias
UMLS CUI [1]
C1277698
Time of blood sample taken
Description

time of blood sample

Data type

time

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0040223
Comments
Description

comment

Data type

text

Alias
UMLS CUI [1]
C0947611
URINALYSIS
Description

URINALYSIS

Alias
UMLS CUI-1
C0042014
A urine sample has been taken for urinalysis?
Description

urine sample taken

Data type

text

Alias
UMLS CUI [1]
C0200354
Time of urine sample taken
Description

time urine sample taken

Data type

time

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0040223
Comments
Description

comment

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

screening & final examination laboratory collections 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
Screening (Screening)
CL Item
Final Examination (Final Examination)
treatment
Item
Treatment
text
C0087111 (UMLS CUI [1])
initials
Item
Initials
text
C2986440 (UMLS CUI [1])
Item Group
CLINICAL CHEMISTRY & HEMATOLOGY
C0008000 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
Item
A blood sample has been taken for clinical chemistry and hematology (including Hepatitis B/C surface antigen, HIV tests and coagulation)?
text
C1277698 (UMLS CUI [1])
blood sample taken
Code List
A blood sample has been taken for clinical chemistry and hematology (including Hepatitis B/C surface antigen, HIV tests and coagulation)?
CL Item
Yes (Yes)
CL Item
No (No)
time of blood sample
Item
Time of blood sample taken
time
C0200345 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
comment
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
URINALYSIS
C0042014 (UMLS CUI-1)
Item
A urine sample has been taken for urinalysis?
text
C0200354 (UMLS CUI [1])
urine sample taken
Code List
A urine sample has been taken for urinalysis?
CL Item
Yes (Yes)
CL Item
No (No)
time urine sample taken
Item
Time of urine sample taken
time
C0200354 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
comment
Item
Comments
text
C0947611 (UMLS CUI [1])
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