ID

24285

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 1 Laboratory Collections 2

Keywords

Versions (1)
  1. 7/28/17 7/28/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 28, 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 1 Laboratory Collections 2

English

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 1 Laboratory Collections 2

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 Baseline Signs and Symptoms 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 Take
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
Dextrometorphan Urine Collection (0-8 hrs)
Description

Dextrometorphan Urine Collection (0-8 hrs)

Alias
UMLS CUI-1
C0200354
Start Date and Time
Description

urine collection start date and time

Data type

datetime

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C3897500
Stop Date and Time
Description

urine collection stop date and time

Data type

datetime

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C2746065
UMLS CUI [1,3]
C1264639
Velume of Urine
Description

urine volume

Data type

text

Alias
UMLS CUI [1]
C1287298
Result
Description

urine flow

Data type

float

Measurement units
  • mL/min
Alias
UMLS CUI [1]
C0232851
mL/min
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Similar models

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 1 Laboratory Collections 2

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 Baseline Signs and Symptoms 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
+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 Take
boolean
C0005834 (UMLS CUI [1])
pharmacokinetics comment
Item
Comments
text
C0031328 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Item Group
Dextrometorphan Urine Collection (0-8 hrs)
C0200354 (UMLS CUI-1)
urine collection start date and time
Item
Start Date and Time
datetime
C0200354 (UMLS CUI [1,1])
C3897500 (UMLS CUI [1,2])
urine collection stop date and time
Item
Stop Date and Time
datetime
C0200354 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
urine volume
Item
Velume of Urine
text
C1287298 (UMLS CUI [1])
urine flow
Item
Result
float
C0232851 (UMLS CUI [1])
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