ID
36956
Beskrivning
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
Nyckelord
Versioner (1)
- 2019-06-23 2019-06-23 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
23 juni 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146
Dosing Session 3
- StudyEvent: ODM
Beskrivning
Pregnancy Test
Alias
- UMLS CUI-1
- C0032976
Beskrivning
Pregnancy Tests, Applicable
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C1706839
Beskrivning
Pregnancy Tests, Diagnostic procedures performed
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C3259360
Beskrivning
Pregnancy Tests, Sampling, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
Beskrivning
Pregnancy Tests, Result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C1274040
Beskrivning
Drugs of Abuse
Alias
- UMLS CUI-1
- C0013146
Beskrivning
Drug screen, Sampling, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
Beskrivning
Drug screen, Illicit Drugs
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0086190
Beskrivning
Drug screen, Result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C1274040
Beskrivning
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Vital Signs Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2826644
Beskrivning
Vital Signs Time, Planned
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2826762
- UMLS CUI [1,2]
- C1301732
Beskrivning
Systolic Pressure
Datatyp
integer
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Diastolic blood pressure
Datatyp
integer
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Heart rate
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Pharmacokinetic Sampling
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0870078
Beskrivning
Pharmacokinetic aspects, Sampling, Numbers
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0851347
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0237753
Beskrivning
Pharmacokinetic aspects, Sampling, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
Beskrivning
Pharmacokinetic aspects, Sampling, Relative time, Planned
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0851347
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0439564
- UMLS CUI [1,4]
- C1301732
Beskrivning
Pharmacokinetic aspects, Sampling, Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0040223
Beskrivning
Pharmacokinetic aspects, Sampling, Numbers
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0237753
Beskrivning
Pharmacokinetic aspects, Sampling, Taken
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C1883727
Beskrivning
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Beskrivning
Experimental drug, Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beskrivning
Experimental drug, End Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beskrivning
Experimental drug, Changed status
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0443172
Beskrivning
Experimental drug, Changed status, Details
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0443172
- UMLS CUI [1,3]
- C1522508
Similar models
Dosing Session 3
- 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])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,2])
C0870078 (UMLS CUI-2)
C0870078 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
C0870078 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])