ID
36957
Beschreibung
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
Stichworte
Versionen (1)
- 23.06.19 23.06.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
23. Juni 2019
DOI
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Lizenz
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
Beschreibung
Prepgnancy Test
Alias
- UMLS CUI-1
- C0032976
Beschreibung
Pregnancy Tests, Applicable
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C1706839
Beschreibung
Pregnancy Tests, Diagnostic procedures performed
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C3259360
Beschreibung
Pregnancy Tests, Sampling, Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
Beschreibung
Pregnancy Tests, Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C1274040
Beschreibung
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Vital Signs Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2826644
Beschreibung
Systolic Pressure
Datentyp
integer
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Diastolic blood pressure
Datentyp
integer
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Heart rate
Datentyp
integer
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Electrocardiogram
Alias
- UMLS CUI-1
- C1623258
Beschreibung
Electrocardiogram Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2826640
Beschreibung
Electrocardiogram, Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0040223
Beschreibung
Electrocardiography, Heart rate
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0018810
Beschreibung
Electrocardiogram: P-R interval
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1]
- C0429087
Beschreibung
Electrocardiography, QRS complex duration
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0429025
Beschreibung
Electrocardiography, QT interval - finding
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1287082
Beschreibung
Electrocardiography, QTc interval
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0489625
Beschreibung
Electrocardiography, Abnormality
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1704258
Beschreibung
Electrocardiography, Abnormality, Clinical Significance
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C2826293
Beschreibung
Electrocardiography, Abnormality, Rhythm
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0199556
Beschreibung
Electrocardiography, Abnormality, P-Wave shifting Morphology
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C2216025
Beschreibung
Electrocardiography, Abnormality, Cardiac Conduction
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0232217
Beschreibung
Electrocardiography, Abnormality, Depolarization, Repolarization
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C1331539
- UMLS CUI [1,4]
- C3279217
Beschreibung
Electrocardiography, Abnormality, Other
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
Beschreibung
Electrocardiography, Abnormality, Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0947611
Beschreibung
Laboratory Data Abnormalities - Hematology Abnormalities
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0474523
Beschreibung
Laboratory, Code
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0805701
Beschreibung
Laboratory Procedures, Hematology finding, Sampling, Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0474523
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0011008
Beschreibung
Laboratory Procedures, Hematology finding, Sampling, Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0474523
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0040223
Beschreibung
Laboratory Procedures, Hematology finding, Abnormality, Clinical Significance
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0474523
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [1,4]
- C2826293
Beschreibung
Laboratory Data Abnormalities - Clinical Chemistry Abnormalities
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0008000
- UMLS CUI-3
- C1704258
Beschreibung
Laboratory, Code
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0805701
Beschreibung
Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0011008
Beschreibung
Laboratory Procedures, Chemistry, Clinical, Sampling, Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0040223
Beschreibung
Laboratory Procedures, Chemistry, Clinical, Abnormality, Clinical Significance
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [1,4]
- C2826293
Beschreibung
Laboratory Data Abnormalities - Urinalysis Abnormalities
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0042014
- UMLS CUI-3
- C1704258
Beschreibung
Laboratory, Code
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0805701
Beschreibung
Laboratory Procedures, Urinalysis , Sampling, Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0042014
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0011008
Beschreibung
Laboratory Procedures, Urinalysis , Sampling, Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0042014
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0040223
Beschreibung
Laboratory Procedures, Urinalysis, Abnormality, Clinical Significance
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0042014
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [1,4]
- C2826293
Ähnliche Modelle
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])