ID

25709

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 (2)
  1. 2017-09-11 2017-09-11 -
  2. 2017-09-12 2017-09-12 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

11 september 2017

DOI

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Creative Commons BY-NC 3.0
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visit 1,2,3 & 4 dosing details PK and tolerability of ropinirole as 5 new formulations 101468/197

Engelsk

visit 1,2,3 & 4 dosing details 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
Date
Beskrivning

date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Number of Visit
Beskrivning

visit number

Datatyp

text

Alias
UMLS CUI [1]
C1549755
Treatment
Beskrivning

treatment

Datatyp

text

Alias
UMLS CUI [1]
C0087111
Dosing Details
Beskrivning

Dosing Details

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
Actual time of dosing
Beskrivning

time of dosing

Datatyp

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Dose checked by:
Beskrivning

dose checked

Datatyp

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1283174
Dose administered by
Beskrivning

dose administered

Datatyp

text

Alias
UMLS CUI [1]
C2348343
Treatment
Beskrivning

Please tick the appropriate treatment.

Datatyp

text

Alias
UMLS CUI [1]
C0087111
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Similar models

visit 1,2,3 & 4 dosing details 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])
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
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)
treatment
Item
Treatment
text
C0087111 (UMLS CUI [1])
Item Group
Dosing Details
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
time of dosing
Item
Actual time of dosing
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
dose checked
Item
Dose checked by:
text
C0178602 (UMLS CUI [1,1])
C1283174 (UMLS CUI [1,2])
dose administered
Item
Dose administered by
text
C2348343 (UMLS CUI [1])
Item
Treatment
text
C0087111 (UMLS CUI [1])
treatment
Code List
Treatment
CL Item
A (A)
CL Item
B (B)
CL Item
C (C)
CL Item
D (D)
CL Item
E (E)
CL Item
R (R)
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