ID

34977

Beskrivning

Study ID: 101888 Clinical Study ID: FFR101888 Study Title: A randomised, placebo-controlled, four way crossover study to evaluate the effect of double-blind 4000 mcg of orally inhaled GW685698X and of 6.25 mg cellobiose octa-acetate on electrocardiographic parameters, with single-blind 400 mg of oral moxifloxacin as a positive control, in 40 healthy male and female subjects. 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: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Rhinitis, Allergic, Perennial The study consists of a screening, 4 treatment periods (TP) and a follow-up visit. For each TP there is a Day-1 (D-1) and a Day1 (D1). This document contains the standard meal form. It has to be filled in for TP1-4 Day1.

Nyckelord

  1. 2019-02-04 2019-02-04 -
  2. 2019-02-06 2019-02-06 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

6 februari 2019

DOI

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Licens

Creative Commons BY-NC 3.0

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Effect of inhaled Fluticasone furoate and cellobiose octa-acetate on electrocardiographic parameters in healthy subjects, Study-ID: 101888

Standard meal

  1. StudyEvent: ODM
    1. Standard meal
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Beskrivning

Subject identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit type
Beskrivning

Visit type

Datatyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Standard meal
Beskrivning

Standard meal

Alias
UMLS CUI-1
C0444664
Start Date
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0444664
Planned relative time
Beskrivning

Time Relative To Dosing

Datatyp

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0444664
Start time
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0444664
Has the totality of the meal been ingested?
Beskrivning

Ingestion of meal

Datatyp

text

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0205197

Similar models

Standard meal

  1. StudyEvent: ODM
    1. Standard meal
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Visit type
CL Item
TP1D1 (1)
CL Item
TP2D1 (2)
CL Item
TP3D1 (3)
CL Item
TP4D1 (4)
Item Group
Standard meal
C0444664 (UMLS CUI-1)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0444664 (UMLS CUI [1,2])
Item
Planned relative time
integer
C0439564 (UMLS CUI [1,1])
C0444664 (UMLS CUI [1,2])
Code List
Planned relative time
CL Item
2-3h (1)
CL Item
4-6h (2)
CL Item
8-9h (3)
CL Item
11-12h (4)
Start time
Item
Start time
time
C1301880 (UMLS CUI [1,1])
C0444664 (UMLS CUI [1,2])
Item
Has the totality of the meal been ingested?
text
C1998602 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Code List
Has the totality of the meal been ingested?
CL Item
Yes (Y)
CL Item
No (N)

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