ID
32012
Descripción
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
Palabras clave
Versiones (2)
- 8/10/18 8/10/18 -
- 11/10/18 11/10/18 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
11 de octubre de 2018
DOI
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Licencia
Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396
Investigational Product, Treatment Confirmation, Randomisation-Number
Descripción
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Descripción
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
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0304229
Descripción
Date of Dose
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Descripción
Time of Dose
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0040223
Descripción
Treatment Confirmation
Alias
- UMLS CUI-1
- C0750484
- UMLS CUI-2
- C0087111
Descripción
Treatment confirmation
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0750484
- UMLS CUI [1,2]
- C0087111
Descripción
Reason for Treatment modification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2736765
- UMLS CUI [1,2]
- C0087111
Descripción
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])