ID

25531

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2017-09-05 2017-09-05 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

5 september 2017

DOI

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

Engelsk

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

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Focus Panel ID
Beskrivning

focus panel

Datatyp

integer

Alias
UMLS CUI [1]
C3846158
Patient No
Beskrivning

patient number

Datatyp

integer

Alias
UMLS CUI [1]
C1830427
Prior Medication
Beskrivning

Prior Medication

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

prior medication

Datatyp

text

Alias
UMLS CUI [1]
C2826257
Drugs taken
Beskrivning

Drugs taken

Alias
UMLS CUI-1
C0013227
DRUG NAME
Beskrivning

Trade Name Preferred

Datatyp

text

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

e.g. 500mg

Datatyp

integer

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

e.g. BID, PR

Datatyp

text

Alias
UMLS CUI [1]
C3476109
Route
Beskrivning

drug application route

Datatyp

text

Alias
UMLS CUI [1]
C0013153
Indication
Beskrivning

medication indication

Datatyp

text

Alias
UMLS CUI [1]
C3146298
Duration
Beskrivning

e.g. 6 years

Datatyp

text

Alias
UMLS CUI [1]
C0449238
End Date
Beskrivning

end date of medication

Datatyp

date

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

continuing medication

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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