ID

25715

Descripción

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

Palabras clave

Versiones (1)
  1. 12/9/17 12/9/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

12 de septiembre de 2017

DOI

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Licencia

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

Inglés

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

1 formularios  
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Focus Panel ID
Descripción

focus panel

Tipo de datos

integer

Alias
UMLS CUI [1]
C3846158
Patient No
Descripción

patient number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1830427
Concomitant Medication
Descripción

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Has the subj ect taken any medication after the first dose of study medication or are there any concomitant medication changes since the start of the study?
Descripción

changes in concomitant medication

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0392747
UMLS CUI [1,2]
C2347852
Concomitant Medication
Descripción

Concomitant Medication

Alias
UMLS CUI-1
C2347852
DRUG NAME
Descripción

Trade Name Preferred

Tipo de datos

text

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

e.g. 500 mg

Tipo de datos

integer

Alias
UMLS CUI [1]
C1960417
Frequency of this Dose
Descripción

e.g. BID, PR

Tipo de datos

text

Alias
UMLS CUI [1]
C3476109
Route
Descripción

route of administration

Tipo de datos

text

Alias
UMLS CUI [1]
C0013153
Indication
Descripción

indication

Tipo de datos

text

Alias
UMLS CUI [1]
C3146298
Start Date and Time
Descripción

24hr - clock

Tipo de datos

datetime

Alias
UMLS CUI [1]
C3897500
End Date and Time
Descripción

24hr - clock

Tipo de datos

datetime

Alias
UMLS CUI [1]
C3899266
Continuing at end of study?
Descripción

continuing therapy

Tipo de datos

text

Alias
UMLS CUI [1]
C1553904
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Similar models

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

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
Concomitant Medication
C2347852 (UMLS CUI-1)
Item
Has the subj ect taken any medication after the first dose of study medication or are there any concomitant medication changes since the start of the study?
text
C0392747 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
changes in concomitant medication
Code List
Has the subj ect taken any medication after the first dose of study medication or are there any concomitant medication changes since the start of the study?
CL Item
Yes (Yes)
CL Item
No (No)
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
medication name
Item
DRUG NAME
text
C2360065 (UMLS CUI [1])
single dose characteristics
Item
Single Dose/Unit
integer
C1960417 (UMLS CUI [1])
medication frequency
Item
Frequency of this Dose
text
C3476109 (UMLS CUI [1])
route of administration
Item
Route
text
C0013153 (UMLS CUI [1])
indication
Item
Indication
text
C3146298 (UMLS CUI [1])
start date and time
Item
Start Date and Time
datetime
C3897500 (UMLS CUI [1])
end date and time
Item
End Date and Time
datetime
C3899266 (UMLS CUI [1])
Item
Continuing at end of study?
text
C1553904 (UMLS CUI [1])
continuing therapy
Code List
Continuing at end of study?
CL Item
Yes (Yes)
CL Item
No (No)
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