ID

25529

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. 9/4/17 9/4/17 -
  2. 9/4/17 9/4/17 -
  3. 9/5/17 9/5/17 -
Uploaded on

September 5, 2017

DOI

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License

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

English

screening physical examination 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
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Body Area
Description

body area

Data type

text

Alias
UMLS CUI [1]
C1268086
Status
Description

status

Data type

text

Alias
UMLS CUI [1]
C0449438
Description of abnormality
Description

abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Investigator
Description

Investigator

Alias
UMLS CUI-1
C2826892
Investigator's signature
Description

investigator's signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
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Similar models

screening physical examination 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 Group
Physical Examination
C0031809 (UMLS CUI-1)
Item
Body Area
text
C1268086 (UMLS CUI [1])
body area
Code List
Body Area
CL Item
Eyes, ears, nose, mouth, throat (Eyes, ears, nose, mouth, throat)
C0015392 (UMLS CUI-1)
C0013443 (UMLS CUI-3)
C0028429 (UMLS CUI-5)
C0230028 (UMLS CUI-7)
C0031354 (UMLS CUI-9)
(Comment:en)
CL Item
Neck/thyroid (Neck/thyroid)
C0027530 (UMLS CUI-1)
C0040132 (UMLS CUI-3)
(Comment:en)
CL Item
Spine (Spine)
C0037949 (UMLS CUI-1)
(Comment:en)
CL Item
Chest/lungs (Chest/lungs)
C0817096 (UMLS CUI-1)
C0024109 (UMLS CUI-3)
(Comment:en)
CL Item
Heart (Heart)
C0018787 (UMLS CUI-1)
(Comment:en)
CL Item
Vascular system (Vascular system)
C0489903 (UMLS CUI-1)
(Comment:en)
CL Item
Lymph nodes (Lymph nodes)
C0024204 (UMLS CUI-1)
(Comment:en)
CL Item
Abdomen (Abdomen)
C0000726 (UMLS CUI-1)
(Comment:en)
CL Item
Extremities (Extremities)
C0436150 (UMLS CUI-1)
(Comment:en)
CL Item
Nervous system/reflexes (Nervous system/reflexes)
C0027763 (UMLS CUI-1)
C0034929 (UMLS CUI-3)
(Comment:en)
CL Item
Skin (Skin)
CL Item
Musculoskeletal system (Musculoskeletal system)
Item
Status
text
C0449438 (UMLS CUI [1])
status
Code List
Status
CL Item
Normal (Normal)
CL Item
Abnormal/Pathological (Abnormal/Pathological)
CL Item
Not examined (Not examined)
abnormality
Item
Description of abnormality
text
C1704258 (UMLS CUI [1])
Item Group
Investigator
C2826892 (UMLS CUI-1)
investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
date
Item
Date
date
C0011008 (UMLS CUI [1])
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