ID

31851

Beschrijving

This ODM-file contains a form to fill in findings of the laboratory, serology and pregnancy testing. To be assessed at Day -1 of Period 1 and 2. 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

Trefwoorden

  1. 03-10-18 03-10-18 -
  2. 07-10-18 07-10-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

3 oktober 2018

DOI

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Licentie

Creative Commons BY-NC 3.0

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Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet 106396

Vital Signs Day -1 of Period 1 and 2

Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschrijving

Visit Date

Datatype

date

Alias
UMLS CUI [1]
C1320303
Visit Type
Beschrijving

Visit Type

Datatype

text

Alias
UMLS CUI [1]
C3641100
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Beschrijving

Date of the measurement of the vital signs

Datatype

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Time
Beschrijving

Time of the measurement of the vital signs

Datatype

time

Alias
UMLS CUI [1]
C2826762
Blood pressure Systolic/Diastolic
Beschrijving

Sitting

Datatype

text

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Heart rate
Beschrijving

Heart rate

Datatype

text

Maateenheden
  • beats/minute
Alias
UMLS CUI [1]
C0018810
beats/minute

Similar models

Vital Signs Day -1 of Period 1 and 2

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Visit Type
Item
Visit Type
text
C3641100 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Date of the measurement of the vital signs
Item
Date
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of the measurement of the vital signs
Item
Time
time
C2826762 (UMLS CUI [1])
Blood pressure
Item
Blood pressure Systolic/Diastolic
text
C0005823 (UMLS CUI [1])
Heart rate
Item
Heart rate
text
C0018810 (UMLS CUI [1])

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