ID

33958

Beskrivning

Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma The study consists of a screening, 4 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) This document contains the Pharmacokinetics Blood form. It has to be filled in for TP1-4 day 7 for each and if required for repeat.

Länk

https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026

Nyckelord

Versioner (1)
  1. 09.01.19 09.01.19 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

9. Januar 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026

Engelsk

Pharmacokinetics Blood

1 Formulär  
  1. StudyEvent: ODM
    1. Pharmacokinetics Blood
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beskrivning

Subject number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Treatment period
Beskrivning

Treatment period

Datatyp

integer

Alias
UMLS CUI [1]
C0087111
Dosing date [read only]
Beskrivning

day month year Item is not required.

Datatyp

date

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
Dosing time [read only]
Beskrivning

00:00-23:59 Item is not required.

Datatyp

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Pharmacokinetics Blood
Beskrivning

Pharmacokinetics Blood

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C0005767
Planned relative time
Beskrivning

Planned relative time

Datatyp

integer

Alias
UMLS CUI [1]
C0439564
Actual time
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0031328
Actual date
Beskrivning

day month year. Only for timepoints >= 12 hours

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0031328
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Similar models

Pharmacokinetics Blood

1 Formulär
  1. StudyEvent: ODM
    1. Pharmacokinetics Blood
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item
Treatment period
integer
C0087111 (UMLS CUI [1])
Treatment type/Treatment period and Day
Code List
Treatment period
CL Item
TP1D7 (1)
CL Item
TP2D7 (2)
CL Item
TP4D7 (4)
CL Item
TP3D7 (3)
CL Item
Repeat (5)
Dosing date
Item
Dosing date [read only]
date
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of dosing
Item
Dosing time [read only]
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Pharmacokinetics Blood
C0031327 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned relative time
integer
C0439564 (UMLS CUI [1])
Dosing Time
Code List
Planned relative time
CL Item
Pre Dose (1)
CL Item
5 min (2)
CL Item
10 min (3)
CL Item
30 min (4)
CL Item
1 hour (5)
CL Item
2 hours (6)
CL Item
4 hours (7)
CL Item
8 hours (8)
CL Item
12 hours (9)
CL Item
16 hours (10)
CL Item
24 hours (11)
CL Item
Repeat (12)
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,3])
Actual date
Item
Actual date
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,3])
Tillbaka till toppen 

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