ID

33958

Description

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.

Link

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

Keywords

  1. 1/9/19 1/9/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 9, 2019

DOI

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License

Creative Commons BY-NC 3.0

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Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026

Pharmacokinetics Blood

  1. StudyEvent: ODM
    1. Pharmacokinetics Blood
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Treatment period
Description

Treatment period

Data type

integer

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

day month year Item is not required.

Data type

date

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

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

Data type

time

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

Pharmacokinetics Blood

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

Planned relative time

Data type

integer

Alias
UMLS CUI [1]
C0439564
Actual time
Description

00:00-23:59

Data type

time

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

day month year. Only for timepoints >= 12 hours

Data type

date

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

Similar models

Pharmacokinetics Blood

  1. StudyEvent: ODM
    1. Pharmacokinetics Blood
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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])
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])

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