ID
36957
Description
Study ID: 102146 Clinical Study ID: SUM102146 Study Title: An open-label, randomized, three-period crossover study to demonstrate the bioequivalence of sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose after dose-normalization, and to assess the relative bioavailability of 4 mg sumatriptan injected using the STATdose device compared to 4 mg sumatriptan injected manually 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: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders
Keywords
Versions (1)
- 6/23/19 6/23/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
June 23, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146
Follow-Up
- StudyEvent: ODM
Description
Prepgnancy Test
Alias
- UMLS CUI-1
- C0032976
Description
Pregnancy Tests, Applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C1706839
Description
Pregnancy Tests, Diagnostic procedures performed
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C3259360
Description
Pregnancy Tests, Sampling, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
Description
Pregnancy Tests, Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C1274040
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Vital Signs Date
Data type
date
Alias
- UMLS CUI [1]
- C2826644
Description
Systolic Pressure
Data type
integer
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic blood pressure
Data type
integer
Alias
- UMLS CUI [1]
- C0428883
Description
Heart rate
Data type
integer
Alias
- UMLS CUI [1]
- C0018810
Description
Electrocardiogram
Alias
- UMLS CUI-1
- C1623258
Description
Electrocardiogram Date
Data type
date
Alias
- UMLS CUI [1]
- C2826640
Description
Electrocardiogram, Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0040223
Description
Electrocardiography, Heart rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0018810
Description
Electrocardiogram: P-R interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0429087
Description
Electrocardiography, QRS complex duration
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0429025
Description
Electrocardiography, QT interval - finding
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1287082
Description
Electrocardiography, QTc interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0489625
Description
Electrocardiography, Abnormality
Data type
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1704258
Description
Electrocardiography, Abnormality, Clinical Significance
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C2826293
Description
Electrocardiography, Abnormality, Rhythm
Data type
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0199556
Description
Electrocardiography, Abnormality, P-Wave shifting Morphology
Data type
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C2216025
Description
Electrocardiography, Abnormality, Cardiac Conduction
Data type
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0232217
Description
Electrocardiography, Abnormality, Depolarization, Repolarization
Data type
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C1331539
- UMLS CUI [1,4]
- C3279217
Description
Electrocardiography, Abnormality, Other
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
Description
Electrocardiography, Abnormality, Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0947611
Description
Laboratory Data Abnormalities - Hematology Abnormalities
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0474523
Description
Laboratory, Code
Data type
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0805701
Description
Laboratory Procedures, Hematology finding, Sampling, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0474523
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0011008
Description
Laboratory Procedures, Hematology finding, Sampling, Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0474523
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0040223
Description
Laboratory Procedures, Hematology finding, Abnormality, Clinical Significance
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0474523
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [1,4]
- C2826293
Description
Laboratory Data Abnormalities - Clinical Chemistry Abnormalities
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0008000
- UMLS CUI-3
- C1704258
Description
Laboratory, Code
Data type
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0805701
Description
Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0011008
Description
Laboratory Procedures, Chemistry, Clinical, Sampling, Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0040223
Description
Laboratory Procedures, Chemistry, Clinical, Abnormality, Clinical Significance
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [1,4]
- C2826293
Description
Laboratory Data Abnormalities - Urinalysis Abnormalities
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0042014
- UMLS CUI-3
- C1704258
Description
Laboratory, Code
Data type
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0805701
Description
Laboratory Procedures, Urinalysis , Sampling, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0042014
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0011008
Description
Laboratory Procedures, Urinalysis , Sampling, Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0042014
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0040223
Description
Laboratory Procedures, Urinalysis, Abnormality, Clinical Significance
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0042014
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [1,4]
- C2826293
Similar models
Follow-Up
- StudyEvent: ODM
C1706839 (UMLS CUI [1,2])
C3259360 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,2])
C0489625 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C2216025 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [1,3])
C3279217 (UMLS CUI [1,4])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C1704258 (UMLS CUI-2)
C0474523 (UMLS CUI-3)
C0805701 (UMLS CUI [1,2])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0474523 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
C0008000 (UMLS CUI-2)
C1704258 (UMLS CUI-3)
C0805701 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0008000 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0008000 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
C0042014 (UMLS CUI-2)
C1704258 (UMLS CUI-3)
C0805701 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0042014 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0042014 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])