ID
34624
Description
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
Keywords
Versions (1)
- 1/20/19 1/20/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
January 20, 2019
DOI
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License
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 1 Form
- StudyEvent: ODM
Description
Urine Drug and Alcohol Screen
Alias
- UMLS CUI-1
- C0373483
- UMLS CUI-2
- C0038586
Description
Urine drug screening, Ethanol measurement, Sampling, Date in time, Time
Data type
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
Description
Urine drug screening, Cocaine
Data type
text
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0009170
Description
Urine drug screening, Amphetamines
Data type
text
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0002667
Description
Urine drug screening, Benzodiazepines
Data type
text
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0005064
Description
Urine drug screening, Cannabinoids
Data type
text
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0006864
Description
Urine drug screening, Opiates
Data type
text
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0376196
Description
Urine drug screening, Barbiturates
Data type
text
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0004745
Description
Urine drug screening, Methadone
Data type
text
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0025605
Description
Urine drug screening, Ethanol measurement
Data type
text
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0202304
Description
Urine Cotinine measurement
Data type
text
Alias
- UMLS CUI [1]
- C1278256
Description
Pregnancy Test
Alias
- UMLS CUI-1
- C0032976
Description
Electronically transferred laboratory data (Blood) - Clinical Chemistry
Alias
- UMLS CUI-1
- C0008000
Description
Chemistry, Clinical; Relative time, Planned
Data type
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
Description
Chemistry, Clinical; Sampling, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
Description
Chemistry, Clinical; Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0040223
Description
Electronically transferred laboratory data (Blood) - Haematology
Alias
- UMLS CUI-1
- C0018941
Description
Hematologic tests, Relative time, Planned
Data type
text
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
Description
Hematologic tests, Sampling, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
Description
Hematologic tests; Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0040223
Description
Electronically transferred laboratory data (Urine) - Urinalysis
Alias
- UMLS CUI-1
- C0042014
Description
Urinalysis, Relative time, Planned
Data type
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
Description
Urinalysis, Sampling, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
Description
Urinalysis, Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0040223
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Body Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Body Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Body mass index
Data type
float
Measurement units
- kg/m2
Alias
- UMLS CUI [1]
- C1305855
Description
Vital Signs Date
Data type
date
Alias
- UMLS CUI [1]
- C2826644
Description
Vital signs, Relative time, Planned
Data type
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
Description
Vital Signs Time
Data type
time
Alias
- UMLS CUI [1]
- C2826762
Description
Systolic Pressure, Supine Position
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0038846
Description
Diastolic blood pressure, Supine Position
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0038846
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Description
12 lead ECG, Number
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0808070
Description
12 lead ECG, Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0808070
Description
12 lead ECG, Relative Time, Planned
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
Description
12 lead ECG, Start time
Data type
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Description
12 lead ECG, Ventricular Rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C2189285
Description
12 lead ECG, PR Interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429087
Description
12 lead ECG, QRS complex duration
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Description
12 lead ECG, QT interval - finding
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1287082
Description
12 lead ECG, Electrocardiogram QT corrected interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
Description
12 lead ECG, QRS Axis
Data type
integer
Measurement units
- degrees
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429012
Description
12 lead ECG, Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
Description
Electronically transferred laboratory data (Blood) - Clinical Chemistry
Alias
- UMLS CUI-1
- C0008000
Description
Chemistry, Clinical; Relative time, Planned
Data type
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
Description
Chemistry, Clinical; Sampling, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
Description
Chemistry, Clinical; Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0040223
Description
Electronically transferred laboratory data (Blood) - Haematology
Alias
- UMLS CUI-1
- C0018941
Description
Hematologic tests, Relative time, Planned
Data type
text
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
Description
Hematologic tests, Sampling, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
Description
Hematologic tests; Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0040223
Description
Electronically transferred laboratory data (Urine) - Urinalysis
Alias
- UMLS CUI-1
- C0042014
Description
Urinalysis, Relative time, Planned
Data type
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
Description
Urinalysis, Sampling, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
Description
Urinalysis, Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0040223
Description
Pharmacokinetics - Blood
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005767
Description
Pharmacokinetic aspects, Blood, Relative time, Planned
Data type
text
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005767
- UMLS CUI [1,3]
- C0439564
- UMLS CUI [1,4]
- C1301732
Description
Pharmacokinetic aspects, Blood, Sampling, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005767
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0011008
Description
Pharmacokinetic aspects, Blood, Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005767
- UMLS CUI [1,3]
- C0040223
Description
Pharmacokinetic aspects, Blood, Sample identification number
Data type
text
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005767
- UMLS CUI [1,3]
- C1299222
Description
Randomisation Number
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Description
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Description
Experimental drug
Data type
text
Alias
- UMLS CUI [1]
- C0304229
Description
Experimental drug, Dosage, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Description
Experimental drug, Dosage, Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0040223
Description
Experimental drug, Daily Dose
Data type
integer
Measurement units
- mg/day
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C2348070
Description
Treatment Confirmation
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C0750484
Description
Therapeutic procedure, Confirmation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C0750484
Description
Therapeutic procedure, Wrong, Indication
Data type
text
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C3827420
- UMLS CUI [1,3]
- C3146298
Similar models
Period 1 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])
C0237753 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
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])