ID

25531

Beschrijving

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

Trefwoorden

  1. 05-09-17 05-09-17 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

5 september 2017

DOI

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Licentie

Creative Commons BY-NC 3.0

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prior medication PK and tolerability of ropinirole as 5 new formulations 101468/197

prior medication PK and tolerability of ropinirole as 5 new formulations 101468/197

Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Focus Panel ID
Beschrijving

focus panel

Datatype

integer

Alias
UMLS CUI [1]
C3846158
Patient No
Beschrijving

patient number

Datatype

integer

Alias
UMLS CUI [1]
C1830427
Prior Medication
Beschrijving

Prior Medication

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

prior medication

Datatype

text

Alias
UMLS CUI [1]
C2826257
Drugs taken
Beschrijving

Drugs taken

Alias
UMLS CUI-1
C0013227
DRUG NAME
Beschrijving

Trade Name Preferred

Datatype

text

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

e.g. 500mg

Datatype

integer

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

e.g. BID, PR

Datatype

text

Alias
UMLS CUI [1]
C3476109
Route
Beschrijving

drug application route

Datatype

text

Alias
UMLS CUI [1]
C0013153
Indication
Beschrijving

medication indication

Datatype

text

Alias
UMLS CUI [1]
C3146298
Duration
Beschrijving

e.g. 6 years

Datatype

text

Alias
UMLS CUI [1]
C0449238
End Date
Beschrijving

end date of medication

Datatype

date

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

continuing medication

Datatype

text

Alias
UMLS CUI [1]
C2826666

Similar models

prior medication PK and tolerability of ropinirole as 5 new formulations 101468/197

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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])
Code List
Continuing at end of study?
CL Item
Yes (Yes)
CL Item
No (No)

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