ID

24323

Description

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

Keywords

Versions (1)
  1. 7/29/17 7/29/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 29, 2017

DOI

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License

Creative Commons BY-NC 3.0
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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

English

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

1 forms  
Clinical Chemistry And Haematology
Description

Clinical Chemistry And Haematology

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

blood sampling date and time

Data type

datetime

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

comment

Data type

text

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

clinical chemistry and hematology normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0205307
UMLS CUI [2,1]
C0018941
UMLS CUI [2,2]
C0205307
PK Sampling
Description

PK Sampling

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

time since dose

Data type

text

Alias
UMLS CUI [1]
C0946444
Date
Description

pharmacokinetics date

Data type

date

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

pharmacokinetics time

Data type

time

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

blood sample

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Comments
Description

pharmacokinetics comment

Data type

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0031328
Dosing Details
Description

Dosing Details

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

dosing date and time

Data type

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:
Description

dose administered

Data type

text

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

dose witnessed

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0682356
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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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