ID

26880

Beschreibung

Study ID: 101468/199 Clinical Study ID: 101468/199 Study Title: An open label study conducted in healthy volunteers to characterize the pharmacokinetics of a new unmarketed formulation of ropinirole 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: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome Documentation part (Visit Description): PK Study Session 7, Day 31

Stichworte

Versionen (1)
  1. 27.10.17 27.10.17 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

27. Oktober 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Pharmacokinetics of a new unmarketed formulation of ropinirole Day 31 101468/199

Englisch

PK Study Session 7, Day 31

1 Formulare  
Vital signs
Beschreibung

Vital signs

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0031809
Timepoint of Vital signs
Beschreibung

Timepoint of Vital signs

Datentyp

integer

Alias
UMLS CUI [1]
C0518766
Date of Vital Signs Examination
Beschreibung

Date of Vital Signs Examination

Datentyp

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Planned Relative Time of Vital signs Examination
Beschreibung

Planned Relative Time

Datentyp

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
Actual time
Beschreibung

of Examination

Datentyp

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Systolic Blood pressure
Beschreibung

Systolic Blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood pressure
Beschreibung

Diastolic Blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject Position
Beschreibung

Subject Position

Datentyp

integer

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
C0518766
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Investigational Product
Beschreibung

Investigational Product

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0244821
Investigational Product
Beschreibung

Investigational Product

Datentyp

integer

Alias
UMLS CUI [1,1]
C0244821
UMLS CUI [1,2]
C0304229
Date of Dose
Beschreibung

Date of Dose

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Time of Dose
Beschreibung

Time of Dose

Datentyp

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Dose
Beschreibung

Dose

Datentyp

float

Maßeinheiten
  • mg/Day
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0304229
mg/Day
Units
Beschreibung

Units

Datentyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0304229
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0304229
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Beschreibung

Treatment confirmation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
If No, record reason(s)
Beschreibung

Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?

Datentyp

text

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
UMLS CUI [2]
C0392360
Pharmacokinetics - Blood
Beschreibung

Pharmacokinetics - Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
UMLS CUI-3
C0304229
Planned Relative Time, check one
Beschreibung

Time Relative to Dosing

Datentyp

integer

Alias
UMLS CUI [1]
C0439564
UMLS CUI [2]
C0005834
Date Blood Sample Taken
Beschreibung

Date Blood Sample Taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Time Blood Sample Taken
Beschreibung

Time Blood Sample Taken

Datentyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
Blood sample taken?
Beschreibung

Blood sample taken

Datentyp

boolean

Alias
UMLS CUI [1]
C1277698
Zum Seitenanfang zurückkehren

Ähnliche Modelle

PK Study Session 7, Day 31

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Vital signs
C0518766 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Item
Timepoint of Vital signs
integer
C0518766 (UMLS CUI [1])
Timepoint of Vital signs
Code List
Timepoint of Vital signs
CL Item
Pre-dose 1 (1)
CL Item
+2 hrs (2)
CL Item
+4 hrs (3)
CL Item
+6 hrs (4)
CL Item
+12 hrs (5)
CL Item
+24 hrs (6)
CL Item
Unscheduled (7)
Date of Vital Signs Examination
Item
Date of Vital Signs Examination
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Planned Relative Time
Item
Planned Relative Time of Vital signs Examination
text
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Actual time
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Systolic Blood pressure
Item
Systolic Blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood pressure
Item
Diastolic Blood pressure
integer
C0428883 (UMLS CUI [1])
Item
Subject Position
integer
C1262869 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Subject Position
Code List
Subject Position
CL Item
Supine (1)
CL Item
Standing (2)
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
C0244821 (UMLS CUI-2)
Item
Investigational Product
integer
C0244821 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Investigational Product
Code List
Investigational Product
CL Item
Ropinirole (1)
Date of Dose
Item
Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time of Dose
Item
Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Dose
Item
Dose
float
C3174092 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Units
Item
Units
text
C1519795 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Route
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Treatment confirmation
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Treatment confirmation
Item
If No, record reason(s)
text
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2])
Item Group
Pharmacokinetics - Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
Item
Planned Relative Time, check one
integer
C0439564 (UMLS CUI [1])
C0005834 (UMLS CUI [2])
Planned Relative Time
Code List
Planned Relative Time, check one
CL Item
Pre-dose (1)
CL Item
+0.25 hrs (2)
CL Item
+0.5 hrs (3)
CL Item
+0.75 hrs (4)
CL Item
+1 hr (5)
CL Item
+2 hrs (6)
CL Item
+3 hrs (7)
CL Item
+4 hrs (8)
CL Item
+6 hrs (9)
CL Item
+8 hrs (10)
CL Item
+12 hrs (11)
CL Item
+16 hrs (12)
CL Item
+24 hrs (13)
Date Blood Sample Taken
Item
Date Blood Sample Taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time Blood Sample Taken
Item
Time Blood Sample Taken
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Blood sample taken
Item
Blood sample taken?
boolean
C1277698 (UMLS CUI [1])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video