ID
34625
Beskrivning
TEST StudyStudy ID: 102863 Clinical Study ID: 102863 Study Title: A randomized, open-label, two-period, period-balanced, crossover study with three parallel groups to evaluate the relative bioavailability of single oral doses of SB 497115-GR phase III tablets [50 mg, 75 mg, 100 mg] compared to SB-497115-GR phase II tablets [25 mg and 50 mg] in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Trade Name: Eltrombopag Study Indication: Thrombocytopenia
Nyckelord
Versioner (1)
- 2019-01-20 2019-01-20 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
20 januari 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Relative Bioavailability of SB 497115-GR phase III tablets compared to SB-497115-GR phase II tablets 102863
Period 2 Form
- StudyEvent: ODM
Beskrivning
Urine Drug and Alcohol Screen
Alias
- UMLS CUI-1
- C0373483
- UMLS CUI-2
- C0038586
Beskrivning
Urine drug screening, Ethanol measurement, Sampling, Date in time, Time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0202304
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0011008
- UMLS CUI [1,5]
- C0040223
Beskrivning
Urine drug screening, Cocaine
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0009170
Beskrivning
Urine drug screening, Amphetamines
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0002667
Beskrivning
Urine drug screening, Benzodiazepines
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0005064
Beskrivning
Urine drug screening, Cannabinoids
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0006864
Beskrivning
Urine drug screening, Opiates
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0376196
Beskrivning
Urine drug screening, Barbiturates
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0004745
Beskrivning
Urine drug screening, Methadone
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0025605
Beskrivning
Urine drug screening, Ethanol measurement
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0202304
Beskrivning
Urine Cotinine measurement
Datatyp
text
Alias
- UMLS CUI [1]
- C1278256
Beskrivning
Pregnancy Test
Alias
- UMLS CUI-1
- C0032976
Beskrivning
Electronically transferred laboratory data (Blood) - Clinical Chemistry
Alias
- UMLS CUI-1
- C0008000
Beskrivning
Chemistry, Clinical; Relative time, Planned
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
Beskrivning
Chemistry, Clinical; Sampling, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
Beskrivning
Chemistry, Clinical; Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0040223
Beskrivning
Electronically transferred laboratory data (Blood) - Haematology
Alias
- UMLS CUI-1
- C0018941
Beskrivning
Hematologic tests, Relative time, Planned
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
Beskrivning
Hematologic tests, Sampling, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
Beskrivning
Hematologic tests; Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0040223
Beskrivning
Electronically transferred laboratory data (Urine) - Urinalysis
Alias
- UMLS CUI-1
- C0042014
Beskrivning
Urinalysis, Relative time, Planned
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
Beskrivning
Urinalysis, Sampling, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
Beskrivning
Urinalysis, Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0040223
Beskrivning
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Vital Signs Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2826644
Beskrivning
Vital signs, Relative time, Planned
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
Beskrivning
Vital Signs Time
Datatyp
time
Alias
- UMLS CUI [1]
- C2826762
Beskrivning
Systolic Pressure, Supine Position
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0038846
Beskrivning
Diastolic blood pressure, Supine Position
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0038846
Beskrivning
Heart Rate
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beskrivning
12 lead ECG, Number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0808070
Beskrivning
12 lead ECG, Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0808070
Beskrivning
12 lead ECG, Relative Time, Planned
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
Beskrivning
12 lead ECG, Start time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Beskrivning
12 lead ECG, Ventricular Rate
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C2189285
Beskrivning
12 lead ECG, PR Interval
Datatyp
integer
Måttenheter
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429087
Beskrivning
12 lead ECG, QRS complex duration
Datatyp
integer
Måttenheter
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Beskrivning
12 lead ECG, QT interval - finding
Datatyp
integer
Måttenheter
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1287082
Beskrivning
12 lead ECG, Electrocardiogram QT corrected interval
Datatyp
integer
Måttenheter
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
Beskrivning
12 lead ECG, QRS Axis
Datatyp
integer
Måttenheter
- degrees
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429012
Beskrivning
12 lead ECG, Result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
Beskrivning
Electronically transferred laboratory data (Blood) - Clinical Chemistry
Alias
- UMLS CUI-1
- C0008000
Beskrivning
Chemistry, Clinical; Relative time, Planned
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
Beskrivning
Chemistry, Clinical; Sampling, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
Beskrivning
Chemistry, Clinical; Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0040223
Beskrivning
Electronically transferred laboratory data (Blood) - Haematology
Alias
- UMLS CUI-1
- C0018941
Beskrivning
Hematologic tests, Relative time, Planned
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
Beskrivning
Hematologic tests, Sampling, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
Beskrivning
Hematologic tests; Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0040223
Beskrivning
Electronically transferred laboratory data (Urine) - Urinalysis
Alias
- UMLS CUI-1
- C0042014
Beskrivning
Urinalysis, Relative time, Planned
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
Beskrivning
Urinalysis, Sampling, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
Beskrivning
Urinalysis, Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0040223
Beskrivning
Pharmacokinetics - Blood
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005767
Beskrivning
Pharmacokinetic aspects, Blood, Relative time, Planned
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005767
- UMLS CUI [1,3]
- C0439564
- UMLS CUI [1,4]
- C1301732
Beskrivning
Pharmacokinetic aspects, Blood, Sampling, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005767
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0011008
Beskrivning
Pharmacokinetic aspects, Blood, Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005767
- UMLS CUI [1,3]
- C0040223
Beskrivning
Pharmacokinetic aspects, Blood, Sample identification number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005767
- UMLS CUI [1,3]
- C1299222
Beskrivning
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Beskrivning
Experimental drug
Datatyp
text
Alias
- UMLS CUI [1]
- C0304229
Beskrivning
Experimental drug, Dosage, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Beskrivning
Experimental drug, Dosage, Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0040223
Beskrivning
Experimental drug, Daily Dose
Datatyp
integer
Måttenheter
- mg/day
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C2348070
Beskrivning
Treatment Confirmation
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C0750484
Beskrivning
Therapeutic procedure, Confirmation
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C0750484
Beskrivning
Therapeutic procedure, Wrong, Indication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C3827420
- UMLS CUI [1,3]
- C3146298
Similar models
Period 2 Form
- StudyEvent: ODM
C0038586 (UMLS CUI-2)
C0202304 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
C0002667 (UMLS CUI [1,2])
C0005064 (UMLS CUI [1,2])
C0006864 (UMLS CUI [1,2])
C0004745 (UMLS CUI [1,2])
C0025605 (UMLS CUI [1,2])
C0202304 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C1301880 (UMLS CUI [1,2])
C2189285 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
C0429012 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0005767 (UMLS CUI-2)
C0005767 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0005767 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C2348070 (UMLS CUI [1,2])
C0750484 (UMLS CUI-2)
C0750484 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])