ID

25531

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. 9/5/17 9/5/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 5, 2017

DOI

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License

Creative Commons BY-NC 3.0
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prior medication PK and tolerability of ropinirole as 5 new formulations 101468/197

English

prior medication 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
Prior Medication
Description

Prior Medication

Alias
UMLS CUI-1
C2826257
Has the subject taken any medication within 14 days prior to the first dose of study medication?
Description

prior medication

Data type

text

Alias
UMLS CUI [1]
C2826257
Drugs taken
Description

Drugs taken

Alias
UMLS CUI-1
C0013227
DRUG NAME
Description

Trade Name Preferred

Data type

text

Alias
UMLS CUI [1]
C2360065
Single Dose/Unit
Description

e.g. 500mg

Data type

integer

Alias
UMLS CUI [1]
C3174092
Frequency of this Dose
Description

e.g. BID, PR

Data type

text

Alias
UMLS CUI [1]
C3476109
Route
Description

drug application route

Data type

text

Alias
UMLS CUI [1]
C0013153
Indication
Description

medication indication

Data type

text

Alias
UMLS CUI [1]
C3146298
Duration
Description

e.g. 6 years

Data type

text

Alias
UMLS CUI [1]
C0449238
End Date
Description

end date of medication

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Continuing at end of study?
Description

continuing medication

Data type

text

Alias
UMLS CUI [1]
C2826666
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Similar models

prior medication 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])
Item Group
Prior Medication
C2826257 (UMLS CUI-1)
Item
Has the subject taken any medication within 14 days prior to the first dose of study medication?
text
C2826257 (UMLS CUI [1])
prior medication
Code List
Has the subject taken any medication within 14 days prior to the first dose of study medication?
CL Item
Yes (Yes)
CL Item
No (No)
Item Group
Drugs taken
C0013227 (UMLS CUI-1)
drug name
Item
DRUG NAME
text
C2360065 (UMLS CUI [1])
dose per unit
Item
Single Dose/Unit
integer
C3174092 (UMLS CUI [1])
medication frequency
Item
Frequency of this Dose
text
C3476109 (UMLS CUI [1])
drug application route
Item
Route
text
C0013153 (UMLS CUI [1])
medication indication
Item
Indication
text
C3146298 (UMLS CUI [1])
duration of medication
Item
Duration
text
C0449238 (UMLS CUI [1])
end date of medication
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Continuing at end of study?
text
C2826666 (UMLS CUI [1])
continuing medication
Code List
Continuing at end of study?
CL Item
Yes (Yes)
CL Item
No (No)
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