ID

24394

Beschreibung

Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female 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: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Treatment Period 2 Dosing Details 13-17, PK Sampling 3-5

Stichworte

Versionen (1)
  1. 30.07.17 30.07.17 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

30. Juli 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.

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dosing Details 13-17, PK Sampling 3-5

Englisch

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dosing Details 13-17, PK Sampling 3-5

1 Formulare  
Dosing Details
Beschreibung

Dosing Details

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
Date and time of dosing GW597599
Beschreibung

dosing date and time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Dose checked and administered by:
Beschreibung

dose administered

Datentyp

text

Alias
UMLS CUI [1]
C2348343
Dose checked and witnessed by:
Beschreibung

dose witnessed

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0682356
PK Sampling
Beschreibung

PK Sampling

Alias
UMLS CUI-1
C0031327
Time relative to start of dose
Beschreibung

time since dose

Datentyp

text

Alias
UMLS CUI [1]
C0946444
Date
Beschreibung

pharmacokinetics date

Datentyp

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0011008
Actual Time
Beschreibung

pharmacokinetics time

Datentyp

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0040223
Sample Taken
Beschreibung

blood sample

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
Comment
Beschreibung

pharmacokinetics comment

Datentyp

text

Alias
UMLS CUI [1]
C0031328
Dosing Details
Beschreibung

Dosing Details

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
Date and time of dosing GW597599
Beschreibung

dosing date and time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Dose checked and administered by:
Beschreibung

dose administered

Datentyp

text

Alias
UMLS CUI [1]
C2348343
Dose checked and witnessed by:
Beschreibung

dose witnessed

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0682356
Dosing Details
Beschreibung

Dosing Details

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
Date and time of dosing GW597599
Beschreibung

dosing date and time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Dose checked and administered by:
Beschreibung

dose administered

Datentyp

text

Alias
UMLS CUI [1]
C2348343
Dose checked and witnessed by:
Beschreibung

dose witnessed

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0682356
Dosing Details
Beschreibung

Dosing Details

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
Date and time of dosing dextrometorphan
Beschreibung

dextrometorphan dosing date and time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Dose checked and administered by:
Beschreibung

dose administered

Datentyp

text

Alias
UMLS CUI [1]
C2348343
Dose checked and witnessed by:
Beschreibung

dose witnessed

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0682356
Dosing Details
Beschreibung

Dosing Details

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
Date and time of dosing Midazolam
Beschreibung

midazolam dosing date and time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0026056
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Dose checked and administered by:
Beschreibung

dose administered

Datentyp

text

Alias
UMLS CUI [1]
C2348343
Dose checked and witnessed by:
Beschreibung

dose witnessed

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0682356
PK Sampling
Beschreibung

PK Sampling

Alias
UMLS CUI-1
C0031327
Time relative to start of dose
Beschreibung

time since dose

Datentyp

text

Alias
UMLS CUI [1]
C0946444
Date
Beschreibung

pharmacokinetics date

Datentyp

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0011008
Actual Time
Beschreibung

pharmacokinetics time

Datentyp

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0040223
Sample Taken
Beschreibung

blood sample

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
Comments
Beschreibung

pharmacokinetics comment

Datentyp

text

Alias
UMLS CUI [1]
C0031328
PK Sampling
Beschreibung

PK Sampling

Alias
UMLS CUI-1
C0031327
Time relative to start of dose
Beschreibung

time since dose

Datentyp

text

Alias
UMLS CUI [1]
C0946444
Date
Beschreibung

pharmacokinetics date

Datentyp

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0011008
Actual Time
Beschreibung

pharmacokinetics time

Datentyp

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0040223
Sample Taken
Beschreibung

blood sample

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
Comments
Beschreibung

pharmacokinetics comment

Datentyp

text

Alias
UMLS CUI [1]
C0031328
Zum Seitenanfang zurückkehren

Ähnliche Modelle

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dosing Details 13-17, PK Sampling 3-5

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Dosing Details
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
dosing date and time
Item
Date and time of dosing GW597599
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
dose administered
Item
Dose checked and administered by:
text
C2348343 (UMLS CUI [1])
dose witnessed
Item
Dose checked and witnessed by:
text
C0013227 (UMLS CUI [1,1])
C0682356 (UMLS CUI [1,2])
Item Group
PK Sampling
C0031327 (UMLS CUI-1)
Item
Time relative to start of dose
text
C0946444 (UMLS CUI [1])
time since dose
Code List
Time relative to start of dose
CL Item
Pre-dose (Pre-dose)
CL Item
+1 hr (+1 hr)
CL Item
+2 hrs (+2 hrs)
CL Item
+3 hrs (+3 hrs)
CL Item
+5 hrs (+5 hrs)
CL Item
+8 hrs (+8 hrs)
CL Item
+12 hrs (+12 hrs)
CL Item
+16 hrs (+16 hrs)
CL Item
+24 hrs (+24 hrs)
pharmacokinetics date
Item
Date
date
C0031328 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
pharmacokinetics time
Item
Actual Time
time
C0031328 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
blood sample
Item
Sample Taken
boolean
C0005834 (UMLS CUI [1])
pharmacokinetics comment
Item
Comment
text
C0031328 (UMLS CUI [1])
Item Group
Dosing Details
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
dosing date and time
Item
Date and time of dosing GW597599
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
dose administered
Item
Dose checked and administered by:
text
C2348343 (UMLS CUI [1])
dose witnessed
Item
Dose checked and witnessed by:
text
C0013227 (UMLS CUI [1,1])
C0682356 (UMLS CUI [1,2])
Item Group
Dosing Details
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
dosing date and time
Item
Date and time of dosing GW597599
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
dose administered
Item
Dose checked and administered by:
text
C2348343 (UMLS CUI [1])
dose witnessed
Item
Dose checked and witnessed by:
text
C0013227 (UMLS CUI [1,1])
C0682356 (UMLS CUI [1,2])
Item Group
Dosing Details
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
dextrometorphan dosing date and time
Item
Date and time of dosing dextrometorphan
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
dose administered
Item
Dose checked and administered by:
text
C2348343 (UMLS CUI [1])
dose witnessed
Item
Dose checked and witnessed by:
text
C0013227 (UMLS CUI [1,1])
C0682356 (UMLS CUI [1,2])
Item Group
Dosing Details
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
midazolam dosing date and time
Item
Date and time of dosing Midazolam
datetime
C0026056 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
dose administered
Item
Dose checked and administered by:
text
C2348343 (UMLS CUI [1])
dose witnessed
Item
Dose checked and witnessed by:
text
C0013227 (UMLS CUI [1,1])
C0682356 (UMLS CUI [1,2])
Item Group
PK Sampling
C0031327 (UMLS CUI-1)
Item
Time relative to start of dose
text
C0946444 (UMLS CUI [1])
time since dose
Code List
Time relative to start of dose
CL Item
Pre-dose (Pre-dose)
CL Item
+1 hr (+1 hr)
CL Item
+2 hrs (+2 hrs)
CL Item
+3 hrs (+3 hrs)
CL Item
+5 hrs (+5 hrs)
CL Item
+8 hrs (+8 hrs)
CL Item
+12 hrs (+12 hrs)
CL Item
+16 hrs (+16 hrs)
CL Item
+24 hrs (+24 hrs)
pharmacokinetics date
Item
Date
date
C0031328 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
pharmacokinetics time
Item
Actual Time
time
C0031328 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
blood sample
Item
Sample Taken
boolean
C0005834 (UMLS CUI [1])
pharmacokinetics comment
Item
Comments
text
C0031328 (UMLS CUI [1])
Item Group
PK Sampling
C0031327 (UMLS CUI-1)
Item
Time relative to start of dose
text
C0946444 (UMLS CUI [1])
time since dose
Code List
Time relative to start of dose
CL Item
Pre-dose (Pre-dose)
CL Item
+5 mins (+5 mins)
CL Item
+0.25 hr (+0.25 hr)
CL Item
+0.5 hr (+0.5 hr)
CL Item
+1 hr (+1 hr)
CL Item
+1.5 hrs (+1.5 hrs)
CL Item
+2 hrs (+2 hrs)
CL Item
+3 hrs (+3 hrs)
CL Item
+4 hrs (+4 hrs)
CL Item
+6 hrs (+6 hrs)
CL Item
+8 hrs (+8 hrs)
CL Item
+12 hrs (+12 hrs)
CL Item
+24 hrs (+24 hrs)
pharmacokinetics date
Item
Date
date
C0031328 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
pharmacokinetics time
Item
Actual Time
time
C0031328 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
blood sample
Item
Sample Taken
boolean
C0005834 (UMLS CUI [1])
pharmacokinetics comment
Item
Comments
text
C0031328 (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