ID

41639

Beschrijving

Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Trefwoorden

  1. 29-11-20 29-11-20 -
  2. 29-11-20 29-11-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

29 november 2020

DOI

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Licentie

Creative Commons BY 4.0

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Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673

Screening - Eligibility Question; Subject Identification, Randomisation Number

Date of visit/assessment
Beschrijving

Date of visit/assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/assessment
Beschrijving

Date of visit/assessment

Datatype

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Eligibility Question
Beschrijving

Eligibility Question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Beschrijving

Did the subject meet all the entry criteria?

Datatype

boolean

Alias
UMLS CUI [1]
C1516637
Subject Identification
Beschrijving

Subject Identification

Alias
UMLS CUI-1
C2348585
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Randomisation Number
Beschrijving

Randomisation Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Was the subject able to be randomised?
Beschrijving

Was the subject able to be randomised?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0085732
Randomisation number
Beschrijving

Randomisation number

Datatype

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Date of randomisation
Beschrijving

Date of randomisation

Datatype

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008

Similar models

Screening - Eligibility Question; Subject Identification, Randomisation Number

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Date of visit/assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Subject Identification
C2348585 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Was the subject able to be randomised?
Item
Was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
Randomisation number
Item
Randomisation number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of randomisation
Item
Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

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