ID
32012
Beskrivning
This ODM file contains the form to document the investigational product, the treatment confirmation and the randomisation-number. To be assessed at Day 1 of Period 1 and 2 (randomisation number only at Period 1). Study ID: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet 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; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponsor: GlaxoSmithKline
Nyckelord
Versioner (2)
- 2018-10-08 2018-10-08 -
- 2018-10-11 2018-10-11 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
11 oktober 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396
Investigational Product, Treatment Confirmation, Randomisation-Number
Beskrivning
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Beskrivning
The following list of abbreviations can be used to aid the completion of the appropriate items on the Investigational Product page. If the abbreviation you require is not present on these lists an alternative may be used. INVESTIGATIONAL PRODUCT Code Label 115 = Trexima tablet 116 = Imitrex tablet
Datatyp
text
Alias
- UMLS CUI [1]
- C0304229
Beskrivning
Date of Dose
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Beskrivning
Time of Dose
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0040223
Beskrivning
Treatment Confirmation
Alias
- UMLS CUI-1
- C0750484
- UMLS CUI-2
- C0087111
Beskrivning
Treatment confirmation
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0750484
- UMLS CUI [1,2]
- C0087111
Beskrivning
Reason for Treatment modification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2736765
- UMLS CUI [1,2]
- C0087111
Beskrivning
Randomisation number
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Similar models
Investigational Product, Treatment Confirmation, Randomisation-Number
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0087111 (UMLS CUI-2)
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
C0237753 (UMLS CUI-2)
C0237753 (UMLS CUI [1,2])