ID
31910
Description
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
Keywords
Versions (2)
- 10/8/18 10/8/18 -
- 10/11/18 10/11/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 8, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396
Investigational Product, Treatment Confirmation, Randomisation-Number
Description
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Description
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
Data type
text
Alias
- UMLS CUI [1]
- C0304229
Description
Date of Dose
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Description
Time of Dose
Data type
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0040223
Description
Treatment Confirmation
Alias
- UMLS CUI-1
- C0750484
- UMLS CUI-2
- C0087111
Description
Treatment confirmation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0750484
- UMLS CUI [1,2]
- C0087111
Description
Reason for Treatment modification
Data type
text
Alias
- UMLS CUI [1,1]
- C2736765
- UMLS CUI [1,2]
- C0087111
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Investigational Product, Treatment Confirmation, Randomisation-Number
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