ID
33956
Beschrijving
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 Meal form. It has to be filled in for TP1 D-1, TP1-4 day 7 for each.
Link
https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026
Trefwoorden
Versies (1)
- 09-01-19 09-01-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
9 januari 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026
Meal
- StudyEvent: ODM
Beschrijving
Dosing date and time
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0178602
- UMLS CUI-3
- C0011008
- UMLS CUI-4
- C0040223
Beschrijving
day month year Item is not required. Dummy dosage only for TP1D-1. For Day 7: investigational product dosage.
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [2,1]
- C0032042
- UMLS CUI [2,2]
- C0178602
- UMLS CUI [2,3]
- C0011008
Beschrijving
00:00-23:59 Item is not required. Dummy dosage only for TP1D-1. For Day 7: investigational product dosage.
Datatype
time
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0040223
- UMLS CUI [2,1]
- C0032042
- UMLS CUI [2,2]
- C0178602
- UMLS CUI [2,3]
- C0040223
Beschrijving
Meal
Alias
- UMLS CUI-1
- C1998602
Beschrijving
Hours
Datatype
integer
Alias
- UMLS CUI [1]
- C0439227
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C3842710
- UMLS CUI [1,2]
- C1301880
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C3842710
- UMLS CUI [1,2]
- C1522314
Beschrijving
Ingestion of meal
Datatype
text
Alias
- UMLS CUI [1,1]
- C1998602
- UMLS CUI [1,2]
- C0205197
Beschrijving
Percentage of meal consumed
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439165
- UMLS CUI [1,2]
- C1998602
Similar models
Meal
- StudyEvent: ODM
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0032042 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0011008 (UMLS CUI [2,3])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0032042 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
C1301880 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,2])
C1998602 (UMLS CUI [1,2])