ID

24012

Descripción

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 parts: Demography, Medical History and Physical Examination

Palabras clave

Versiones (1)
  1. 22/7/17 22/7/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

22 de julio de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Demography, Medical History and Physical Examination

Inglés

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Demography, Medical History and Physical Examination

1 formularios  
Demography
Descripción

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Descripción

date of birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Gender
Descripción

gender

Tipo de datos

text

Alias
UMLS CUI [1]
C0079399
Race
Descripción

race

Tipo de datos

text

Alias
UMLS CUI [1]
C0034510
other race
Descripción

race

Tipo de datos

text

Alias
UMLS CUI [1]
C0034510
Height
Descripción

height

Tipo de datos

integer

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Descripción

weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body Mass Index
Descripción

bmi

Tipo de datos

float

Unidades de medida
  • kg/m²
Alias
UMLS CUI [1]
C1305855
kg/m²
Significant medical/surgical history
Descripción

Significant medical/surgical history

Alias
UMLS CUI-1
C0262926
Is the subject suffering from or has he/she ever suffered from any significant medical or surgical condition?
Descripción

medical condition

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0012634
Diagnosis
Descripción

diagnosis

Tipo de datos

text

Alias
UMLS CUI [1]
C0011900
year of first diagnosis
Descripción

year of first diagnosis

Tipo de datos

text

Unidades de medida
  • Month/Year
Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Month/Year
Past/Ongoing
Descripción

ongoing disease

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0012634
Physical Examination
Descripción

Physical Examination

Alias
UMLS CUI-1
C0031809
Date
Descripción

physical examination date

Tipo de datos

date

Alias
UMLS CUI [1]
C2826643
Time
Descripción

physical examintation time

Tipo de datos

time

Alias
UMLS CUI [1]
C2826761
Was the physical examination?
Descripción

physical examination

Tipo de datos

text

Alias
UMLS CUI [1]
C0031809
Record below:
Descripción

physical examination

Tipo de datos

text

Alias
UMLS CUI [1]
C0031809
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Study time
Descripción

study time

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0040223
Date
Descripción

date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Descripción

time

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
Systolic Blood Pressure
Descripción

systolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Descripción

diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart Rate
Descripción

heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
respiratory rate
Descripción

respiratory rate

Tipo de datos

integer

Alias
UMLS CUI [1]
C0231832
12-Lead ECG Monitoring
Descripción

12-Lead ECG Monitoring

Alias
UMLS CUI-1
C0430456
Study time
Descripción

study time

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0040223
Date
Descripción

date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Actual time
Descripción

time

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
Heart Rate
Descripción

heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR
Descripción

pr duration

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C1880446
msec
QRS
Descripción

qrs duration

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C1880451
msec
QT
Descripción

qt duration

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C1880452
msec
QTC
Descripción

qtc duration

Tipo de datos

float

Alias
UMLS CUI [1]
C0860814
ECG normal?
Descripción

ecg normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0522054
Comments
Descripción

ecg comment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0947611
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Similar models

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Demography, Medical History and Physical Examination

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Demography
C0011298 (UMLS CUI-1)
date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
gender
Code List
Gender
CL Item
Male (Male)
CL Item
Female (Female)
Item
Race
text
C0034510 (UMLS CUI [1])
race
Code List
Race
CL Item
American Hispanic (American Hispanic)
CL Item
Arabic/North African (Arabic/North African)
CL Item
Black (Black)
CL Item
East & South East Asia (East & South East Asia)
CL Item
Japanese (Japanese)
CL Item
South Asia (South Asia)
CL Item
White/Caucasian (White/Caucasian)
CL Item
Other (Other)
race
Item
other race
text
C0034510 (UMLS CUI [1])
height
Item
Height
integer
C0005890 (UMLS CUI [1])
weight
Item
Weight
float
C0005910 (UMLS CUI [1])
bmi
Item
Body Mass Index
float
C1305855 (UMLS CUI [1])
Item Group
Significant medical/surgical history
C0262926 (UMLS CUI-1)
medical condition
Item
Is the subject suffering from or has he/she ever suffered from any significant medical or surgical condition?
boolean
C0012634 (UMLS CUI [1])
diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
year of first diagnosis
Item
text
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Past/Ongoing
text
C0549178 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
ongoing disease
Code List
Past/Ongoing
CL Item
Past (Past)
CL Item
Ongoing (Ongoing)
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
physical examination date
Item
Date
date
C2826643 (UMLS CUI [1])
physical examintation time
Item
Time
time
C2826761 (UMLS CUI [1])
Item
Was the physical examination?
text
C0031809 (UMLS CUI [1])
physical examination
Code List
Was the physical examination?
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
physical examination
Item
Record below:
text
C0031809 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Item
Study time
text
C2348563 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
study time
Code List
Study time
CL Item
Screening (Screening)
CL Item
Unscheduled (Unscheduled)
date
Item
Date
date
C0011008 (UMLS CUI [1])
time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
systolic blood pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
diastolic blood pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
heart rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
respiratory rate
Item
integer
C0231832 (UMLS CUI [1])
Item Group
12-Lead ECG Monitoring
C0430456 (UMLS CUI-1)
Item
Study time
text
C2348563 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
study time
Code List
Study time
CL Item
Screening (Screening)
CL Item
Unscheduled (Unscheduled)
date
Item
Date
date
C0011008 (UMLS CUI [1])
time
Item
Actual time
time
C0040223 (UMLS CUI [1])
heart rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
pr duration
Item
PR
float
C1880446 (UMLS CUI [1])
qrs duration
Item
QRS
float
C1880451 (UMLS CUI [1])
qt duration
Item
QT
float
C1880452 (UMLS CUI [1])
qtc duration
Item
QTC
float
C0860814 (UMLS CUI [1])
ecg normal
Item
ECG normal?
boolean
C0522054 (UMLS CUI [1])
ecg comment
Item
Comments
text
C1623258 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
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