ID

24323

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 Laboratory Collections 2, Dosing Details 2-3

Stichworte

Versionen (1)
  1. 29.07.17 29.07.17 -
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GlaxoSmithKline

Hochgeladen am

29. Juli 2017

DOI

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GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Laboratory Collections 2, Dosing Details 2-3

Englisch

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Laboratory Collections 2, Dosing Details

1 Formulare  
Clinical Chemistry And Haematology
Beschreibung

Clinical Chemistry And Haematology

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0018941
Exact date and time of blood sampling
Beschreibung

blood sampling date and time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Comments:
Beschreibung

comment

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Are there any CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on the Adverse Events page.
Beschreibung

clinical chemistry and hematology normal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0205307
UMLS CUI [2,1]
C0018941
UMLS CUI [2,2]
C0205307
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 [1,1]
C0031328
UMLS CUI [1,2]
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
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Ähnliche Modelle

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Laboratory Collections 2, Dosing Details

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Clinical Chemistry And Haematology
C0008000 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
blood sampling date and time
Item
Exact date and time of blood sampling
datetime
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
comment
Item
Comments:
text
C0947611 (UMLS CUI [1])
clinical chemistry and hematology normal
Item
Are there any CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on the Adverse Events page.
boolean
C0008000 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0018941 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
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
+8 hrs (+8 hrs)
CL Item
+12 hrs (+12 hrs)
CL Item
+24 hrs (+24 hrs)
CL Item
+5 hrs (+5 hrs)
CL Item
+16 hrs (+16 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 [1,1])
C0031328 (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])
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