ID

32886

Beskrivning

This form contains a form to document the vital signs assessed in case of early withdrawal. Study ID: 103629 Clinical Study ID: TRX103629 Study Title: An open-label, randomized, 3-period crossover study to evaluate sumatriptan and naproxen pharmacokinetics for a combination tablet product containing sumatriptan/naproxen sodium followed by IMITREX™ (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System and a sumatriptan/naproxen sodium tablet followed by IMITREX (sumatriptan succinate) Injection 6mg administered using the STATdose system compared with an IMITREX tablet 100mg followed by an IMITREX tablet 100mg Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00875784 Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT00875784 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

Länk

https://clinicaltrials.gov/ct2/show/NCT00875784

Nyckelord

  1. 2018-11-18 2018-11-18 -
  2. 2018-11-25 2018-11-25 -
  3. 2018-11-25 2018-11-25 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

18 november 2018

DOI

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Licens

Creative Commons BY-NC 3.0

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Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629

Vital Signs

  1. StudyEvent: ODM
    1. Vital Signs
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Vital Signs
Beskrivning

Vital Signs

Alias
UMLS CUI-1
C0518766
Actual date/time Hr:Min (00:00-23:59)
Beskrivning

Actual date/time

Datatyp

datetime

Alias
UMLS CUI [1]
C1264639
Blood pressure (systolic)
Beskrivning

Blood pressure (systolic)

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure (diastolic)
Beskrivning

Blood pressure (diastolic)

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min

Similar models

Vital Signs

  1. StudyEvent: ODM
    1. Vital Signs
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Actual date/time
Item
Actual date/time Hr:Min (00:00-23:59)
datetime
C1264639 (UMLS CUI [1])
Blood pressure (systolic)
Item
Blood pressure (systolic)
integer
C0871470 (UMLS CUI [1])
Blood pressure (diastolic)
Item
Blood pressure (diastolic)
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])

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