ID
41630
Beskrivning
Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2
Nyckelord
Versioner (3)
- 2020-11-12 2020-11-12 -
- 2020-11-15 2020-11-15 -
- 2020-11-29 2020-11-29 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
29 november 2020
DOI
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Licens
Creative Commons BY 4.0
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Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692
Day 37 - 42, Follow-Up: Vital Signs; Study Drug Administration; Pharmacokinetic Blood Collection, Central Laboratory
Beskrivning
Vital Signs (sitting) - Day 37 - 42, Follow up
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0277814
- UMLS CUI-3
- C1522577
Beskrivning
Vital Signs Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2826644
Beskrivning
Vital Signs Time
Datatyp
time
Alias
- UMLS CUI [1]
- C2826762
Beskrivning
Systolic Blood Pressure
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Diastolic Blood Pressure
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Temperature
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Heart Rate
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Electrocardiogram (Day 37)
Alias
- UMLS CUI-1
- C1623258
Beskrivning
Date ECG Performed
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0011008
Beskrivning
Time ECG Performed
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0040223
Beskrivning
Heart Rate
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
PR Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0429087
Beskrivning
QRS Duration
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0429025
Beskrivning
QT Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C1287082
Beskrivning
QTcB Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C1882512
Beskrivning
QTcF Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C1882513
Beskrivning
RR Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0489636
Beskrivning
Normal Sinus Rhythm?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0232202
Beskrivning
Overall interpretation of ECG
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0459471
Beskrivning
If abnormal, please specify:
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0243095
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [2]
- C2348235
Beskrivning
Central Laboratory - Haematology (Day 37)
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C0018941
Beskrivning
Was the laboratory sample collected? (Haematology)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0005834
- UMLS CUI [2]
- C0018941
Beskrivning
Sample Date (Haematology)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0018941
Beskrivning
Sample Time (Haematology)
Datatyp
time
Alias
- UMLS CUI [1]
- C0005834
- UMLS CUI [2]
- C0018941
- UMLS CUI [3]
- C0040223
Beskrivning
Comment (Haematology)
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2]
- C0018941
Beskrivning
Central Laboratory - Chemistry (Day 37)
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C0008000
Beskrivning
Was the laboratory sample collected? (Chemistry)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0005834
- UMLS CUI [2]
- C0008000
Beskrivning
Sample Date (Chemistry)
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
- UMLS CUI [2]
- C0008000
Beskrivning
Sample Time (Chemistry)
Datatyp
time
Alias
- UMLS CUI [1]
- C0005834
- UMLS CUI [2]
- C0008000
- UMLS CUI [3]
- C0040223
Beskrivning
Comment (Chemistry)
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2]
- C0008000
Beskrivning
Central Laboratory - UA/UDS/Urine HCG/ Urine Chem (Day 37)
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C0864414
- UMLS CUI-3
- C0430056
Beskrivning
Was the laboratory sample collected? (Urine)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0005834
- UMLS CUI [2]
- C0042036
Beskrivning
Sample Date (Urine)
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
- UMLS CUI [2]
- C0042036
Beskrivning
Sample Time (Urine)
Datatyp
time
Alias
- UMLS CUI [1]
- C0005834
- UMLS CUI [2]
- C0042036
- UMLS CUI [3]
- C0040223
Beskrivning
Comment (Urine)
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2]
- C0042036
Beskrivning
Study Drug Administration (80 mg Simvastatin) - Day 38
Alias
- UMLS CUI-1
- C0013153
- UMLS CUI-2
- C0074554
Beskrivning
Was the dose administered?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3174092
- UMLS CUI [2]
- C3469597
Beskrivning
Dose Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0178602
- UMLS CUI [2]
- C0011008
Beskrivning
Dose Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Beskrivning
Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Site of injection
Datatyp
integer
Alias
- UMLS CUI [1]
- C2700396
Beskrivning
Pharmacokinetic Blood Collection (Simvastatin) - Day 38
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005834
- UMLS CUI-3
- C0074554
Beskrivning
Timepoint
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348792
Beskrivning
Sample Date
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
Sample Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beskrivning
Not Done/ Not Collected
Datatyp
integer
Alias
- UMLS CUI [1]
- C1272696
- UMLS CUI [2]
- C0445106
Beskrivning
Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Pharmacokinetic Blood Collection (Albiglutide) - Day 38
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005834
- UMLS CUI-3
- C2607479
Beskrivning
Timepoint
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348792
Beskrivning
Sample Date
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
Sample Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beskrivning
Not Done/ Not Collected
Datatyp
integer
Alias
- UMLS CUI [1]
- C1272696
- UMLS CUI [2]
- C0445106
Beskrivning
Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Pharmacokinetic Blood Collection (Simvastatin) - Day 39
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005834
- UMLS CUI-3
- C0074554
Beskrivning
Timepoint
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348792
Beskrivning
Sample Date
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
Sample Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beskrivning
Not Done/ Not Collected
Datatyp
integer
Alias
- UMLS CUI [1]
- C1272696
- UMLS CUI [2]
- C0445106
Beskrivning
Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Pharmacokinetic Blood Collection (Simvastatin) - Day 40
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005834
- UMLS CUI-3
- C0074554
Beskrivning
Timepoint
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348792
Beskrivning
Sample Date
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
Sample Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beskrivning
Not Done/ Not Collected
Datatyp
integer
Alias
- UMLS CUI [1]
- C1272696
- UMLS CUI [2]
- C0445106
Beskrivning
Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Pharmacokinetic Blood Collection (Simvastatin) - Day 41
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005834
- UMLS CUI-3
- C0074554
Beskrivning
Timepoint
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348792
Beskrivning
Sample Date
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
Sample Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beskrivning
Not Done/ Not Collected
Datatyp
integer
Alias
- UMLS CUI [1]
- C1272696
- UMLS CUI [2]
- C0445106
Beskrivning
Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Pharmacokinetic Blood Collection (Simvastatin) - Day 42
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005834
- UMLS CUI-3
- C0074554
Beskrivning
Timepoint
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348792
Beskrivning
Sample Date
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
Sample Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beskrivning
Not Done/ Not Collected
Datatyp
integer
Alias
- UMLS CUI [1]
- C1272696
- UMLS CUI [2]
- C0445106
Beskrivning
Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Similar models
Day 37 - 42, Follow-Up: Vital Signs; Study Drug Administration; Pharmacokinetic Blood Collection, Central Laboratory
C0750479 (UMLS CUI [1,2])
C0277814 (UMLS CUI-2)
C1522577 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0459471 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0018941 (UMLS CUI-2)
C0018941 (UMLS CUI [2])
C0018941 (UMLS CUI [1,2])
C0018941 (UMLS CUI [2])
C0040223 (UMLS CUI [3])
C0018941 (UMLS CUI [2])
C0008000 (UMLS CUI-2)
C0008000 (UMLS CUI [2])
C0008000 (UMLS CUI [2])
C0008000 (UMLS CUI [2])
C0040223 (UMLS CUI [3])
C0008000 (UMLS CUI [2])
C0864414 (UMLS CUI-2)
C0430056 (UMLS CUI-3)
C0042036 (UMLS CUI [2])
C0042036 (UMLS CUI [2])
C0042036 (UMLS CUI [2])
C0040223 (UMLS CUI [3])
C0042036 (UMLS CUI [2])
C0074554 (UMLS CUI-2)
C3469597 (UMLS CUI [2])
C0011008 (UMLS CUI [2])
C0040223 (UMLS CUI [1,2])
C0005834 (UMLS CUI-2)
C0074554 (UMLS CUI-3)
C0200345 (UMLS CUI [1,2])
C0445106 (UMLS CUI [2])
C0005834 (UMLS CUI-2)
C2607479 (UMLS CUI-3)
C0200345 (UMLS CUI [1,2])
C0445106 (UMLS CUI [2])
C0005834 (UMLS CUI-2)
C0074554 (UMLS CUI-3)
C0200345 (UMLS CUI [1,2])
C0445106 (UMLS CUI [2])
C0005834 (UMLS CUI-2)
C0074554 (UMLS CUI-3)
C0200345 (UMLS CUI [1,2])
C0445106 (UMLS CUI [2])
C0005834 (UMLS CUI-2)
C0074554 (UMLS CUI-3)
C0200345 (UMLS CUI [1,2])
C0445106 (UMLS CUI [2])
C0005834 (UMLS CUI-2)
C0074554 (UMLS CUI-3)
C0200345 (UMLS CUI [1,2])
C0445106 (UMLS CUI [2])