ID

34940

Beschrijving

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.

Trefwoorden

  1. 04-02-19 04-02-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

4 februari 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

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

Pharmacokinetics - Blood sample

Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Beschrijving

Subject identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Visit Type
Beschrijving

Visit Type

Datatype

integer

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

Pharmacokinetics - Blood sample

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

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.

Datatype

integer

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

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

Datatype

date

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

00:00-23:59

Datatype

time

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

Tick if taken

Datatype

boolean

Alias
UMLS CUI [1]
C1510844
Sample Number
Beschrijving

Sample Number

Datatype

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)
Datatype
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)

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial