ID

25706

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 (4)
  1. 8/31/17 8/31/17 -
  2. 9/4/17 9/4/17 -
  3. 9/4/17 9/4/17 -
  4. 9/11/17 9/11/17 -
Uploaded on

September 11, 2017

DOI

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License

Creative Commons BY-NC 3.0
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visit screening, period 1, 2, 3, 4 & final examination pregnancy PK and tolerability of ropinirole as 5 new formulations 101468/197

English

visit screening, period 1, 2, 3, 4 & final examination pregnancy 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
Initials
Description

initials

Data type

text

Alias
UMLS CUI [1]
C2986440
SERUM PREGNANCY TEST
Description

SERUM PREGNANCY TEST

Alias
UMLS CUI-1
C0430060
Was a pregnancy test performed?
Description

pregnancy test

Data type

text

Alias
UMLS CUI [1]
C0032976
Time
Description

time of pregnancy test

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0032976
If "no" above, please specify reason
Description

If "other", specify.

Data type

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0884358
The pregnancy test result was?
Description

pregnancy test result

Data type

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040
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Similar models

visit screening, period 1, 2, 3, 4 & final examination pregnancy 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
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)
CL Item
Final Examination (Final Examination)
treatment
Item
Treatment
text
C0087111 (UMLS CUI [1])
initials
Item
Initials
text
C2986440 (UMLS CUI [1])
Item Group
SERUM PREGNANCY TEST
C0430060 (UMLS CUI-1)
Item
Was a pregnancy test performed?
text
C0032976 (UMLS CUI [1])
pregnancy test
Code List
Was a pregnancy test performed?
CL Item
Yes (Yes)
CL Item
No (No)
time of pregnancy test
Item
Time
time
C0040223 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Item
If "no" above, please specify reason
text
C0032976 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
pregnancy test not done
Code List
If "no" above, please specify reason
CL Item
male (male)
CL Item
other (other)
Item
The pregnancy test result was?
text
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
pregnancy test result
Code List
The pregnancy test result was?
CL Item
Positive (Positive)
CL Item
Negative (Negative)
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