ID

34940

Description

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 Pharmacokinetics - Blood sample form. It has to be filled in for TP1-4 Day1.

Keywords

  1. 2/4/19 2/4/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 4, 2019

DOI

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License

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

Pharmacokinetics - Blood sample

Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Description

Subject identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Type
Description

Visit Type

Data type

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0545082
Pharmacokinetics - Blood sample
Description

Pharmacokinetics - Blood sample

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0178913
Planned relative time
Description

Time Relative To Dosing. PK blood samples will be taken at pre-dose, and one sample during each of the following post-dose time windows: 10-20 mins, 1-2 h, 3-4 h, 6-8 h, 11-12 h and at 24 h.

Data type

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0178913
Date sample taken
Description

day month year If sample is missed or lost, write "NA" in this item.

Data type

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0178913
Actual Time
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0178913
Aliquot
Description

Tick if taken

Data type

boolean

Alias
UMLS CUI [1]
C1510844
Sample Number
Description

Sample Number

Data type

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C1299222

Similar models

Pharmacokinetics - Blood sample

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Item
Visit Type
integer
C0332307 (UMLS CUI [1,1])
C0545082 (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
Pharmacokinetics - Blood sample
C0031328 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
Item
Planned relative time
integer
C0439564 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
Code List
Planned relative time
CL Item
Pre-dose (1)
CL Item
10 - 20 mins (2)
CL Item
1 - 2 h (3)
CL Item
3 - 4 h (4)
CL Item
6 - 8 h (5)
CL Item
11 - 12 h (6)
CL Item
24 h (7)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
Aliquot
Item
Aliquot
boolean
C1510844 (UMLS CUI [1])
Item
Sample Number
integer
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
Code List
Sample Number
CL Item
Pre-dose  (401)
CL Item
10 - 20 mins (402)
CL Item
1 - 2 h (403)
CL Item
3 - 4 h (404)
CL Item
6 - 8 h (405)
CL Item
11 - 12 h (406)
CL Item
24h (407)

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