ID
24531
Beschrijving
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: Follow-Up Physical Examination, b-HCG Pregnancy Test, Vital Signs, 12-Lead ECG Monitoring
Trefwoorden
Versies (1)
- 05-08-17 05-08-17 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
5 augustus 2017
DOI
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Licentie
Creative Commons BY-NC 3.0
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GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Physical Examination, Serum b-HCB Pregnancy Test, Vital Signs, 12-Lead ECG Monitoring
GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Physical Examination, Serum b-HCB Pregnancy Test, Vital Signs, 12-Lead ECG Monitoring
Beschrijving
Serum b-HCG Pregnancy Test (Females Only)
Alias
- UMLS CUI-1
- C0430060
Beschrijving
pregnancy test
Datatype
boolean
Alias
- UMLS CUI [1]
- C0430060
Beschrijving
pregnancy test reason
Datatype
text
Alias
- UMLS CUI [1]
- C0430060
Beschrijving
pregnancy test date and time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0430060
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0040223
Beschrijving
If POSITIVE, withdraw the subject from the study.
Datatype
text
Alias
- UMLS CUI [1]
- C0032976
Beschrijving
Ensure result is included on laboratory report
Datatype
text
Alias
- UMLS CUI [1]
- C1882331
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
study time
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348563
- UMLS CUI [1,2]
- C0040223
Beschrijving
vital signs date
Datatype
date
Alias
- UMLS CUI [1]
- C2826644
Beschrijving
vital signs time
Datatype
time
Alias
- UMLS CUI [1]
- C2826762
Beschrijving
systolic blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
diastolic blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
heart rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
respiratory rate
Datatype
text
Alias
- UMLS CUI [1]
- C0231832
Beschrijving
12-Lead ECG Monitoring
Alias
- UMLS CUI-1
- C0430456
Beschrijving
study time
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348563
- UMLS CUI [1,2]
- C0040223
Beschrijving
ecg date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0011008
Beschrijving
ecg time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0040223
Beschrijving
heart rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
pr duration
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C1880446
Beschrijving
qrs duration
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0429025
Beschrijving
qt duration
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C1880452
Beschrijving
qtc interval
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0855331
Beschrijving
ecg normal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0522054
Beschrijving
ecg comment
Datatype
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 Follow-Up Physical Examination, Serum b-HCB Pregnancy Test, Vital Signs, 12-Lead ECG Monitoring
C0443172 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])