ID

24256

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 Dosing Details, Vital Signs, 12-Lead ECG Monitoring

Keywords

  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 Dosing Details, Vital Signs, 12-Lead ECG Monitoring

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Dosing Details, Vital Signs, 12-Lead ECG Monitoring

Dosing Details
Description

Dosing Details

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

dextrometorphan 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
Date and time of dosing Midazolam
Description

midazolam dosing date and time

Data type

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:
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
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Study Time
Description

study time

Data type

text

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

vital signs date

Data type

date

Alias
UMLS CUI [1]
C2826644
Actual Time
Description

vital signs time

Data type

time

Alias
UMLS CUI [1]
C2826762
Systolic Blood Pressure
Description

systolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Description

diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
HR
Description

heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
12-Lead ECG Monitoring
Description

12-Lead ECG Monitoring

Alias
UMLS CUI-1
C0430456
Study Time
Description

study time

Data type

text

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

ecg date

Data type

date

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0011008
Actual Time
Description

ecg time

Data type

time

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0040223
Heart Rate
Description

heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR
Description

pr interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS
Description

qrs duration

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429025
msec
QT
Description

qt duration

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1880452
msec
QTC
Description

qtc interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0855331
msec
ECG normal?
Description

ecg normal

Data type

boolean

Alias
UMLS CUI [1]
C0522054
Comments
Description

ecg comment

Data type

text

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

Similar models

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Dosing Details, Vital Signs, 12-Lead ECG Monitoring

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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
Vital Signs
C0518766 (UMLS CUI-1)
Item
Study Time
text
C2348563 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Code List
Study Time
CL Item
Pre-dose (Pre-dose)
CL Item
+0.5 hrs (+0.5 hrs)
CL Item
+1 hrs (+1 hrs)
CL Item
+4 hrs (+4 hrs)
CL Item
+12 hrs (+12 hrs)
CL Item
+24 hrs (+24 hrs)
CL Item
Unscheduled (Unscheduled)
vital signs date
Item
Date
date
C2826644 (UMLS CUI [1])
vital signs time
Item
Actual Time
time
C2826762 (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
HR
integer
C0018810 (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])
Code List
Study Time
CL Item
Pre-dose (Pre-dose)
CL Item
+0.5 hrs (+0.5 hrs)
CL Item
+1 hrs (+1 hrs)
CL Item
+4 hrs (+4 hrs)
CL Item
+12 hrs (+12 hrs)
CL Item
+24 hrs (+24 hrs)
CL Item
Unscheduled (Unscheduled)
ecg date
Item
Date
date
C0013798 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
ecg time
Item
Actual Time
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
heart rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
pr interval
Item
PR
float
C0429087 (UMLS CUI [1])
qrs duration
Item
QRS
float
C0429025 (UMLS CUI [1])
qt duration
Item
QT
float
C1880452 (UMLS CUI [1])
qtc interval
Item
QTC
float
C0855331 (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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