ID

41302

Descripción

Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)

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Versiones (1)
  1. 12/8/20 12/8/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

12 de agosto de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)

Inglés

Laboratory Result Data; Urinalysis

1 formularios  
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descripción

Subject Identifier

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Laboratory Result data (Haematology) - 12 Hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)
Descripción

Laboratory Result data (Haematology) - 12 Hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
UMLS CUI-3
C0439568
Date and time sample taken (Haematology)
Descripción

Date and time sample taken (Haematology)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
UMLS CUI [1,4]
C0018941
Has the subject fasted?
Descripción

Has the subject fasted?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015663
Haematology Test (Treatment Period 1, 2, 3, 4, 5)
Descripción

Haematology Test (Treatment Period 1, 2, 3, 4, 5)

Alias
UMLS CUI-1
C0018941
Haematology Test
Descripción

Haematology Test

Tipo de datos

integer

Alias
UMLS CUI [1]
C0018941
Haematology Test Result
Descripción

Haematology Test Result

Tipo de datos

text

Alias
UMLS CUI [1]
C0018941
UMLS CUI [2]
C0587081
Urinalysis - 12 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)
Descripción

Urinalysis - 12 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0439568
Date and time sample taken (Urinalysis)
Descripción

Date and time sample taken (Urinalysis)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
UMLS CUI [2]
C0042014
Urinalysis (Dipstick) Test - 12 hrs (Treatment Period 1, 2, 3, 4, 5)
Descripción

Urinalysis (Dipstick) Test - 12 hrs (Treatment Period 1, 2, 3, 4, 5)

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0430370
Urinalysis (Dipstick) Test
Descripción

Urinalysis (Dipstick) Test

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0430370
Urinalysis (Dipstick) Test Result
Descripción

Urinalysis (Dipstick) Test Result

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0430370
UMLS CUI [2]
C0587081
Urinalysis (Microscopy) Test
Descripción

Urinalysis (Microscopy) Test

Tipo de datos

integer

Alias
UMLS CUI [1]
C0430397
Urinalysis (Microscopy) Test Result
Descripción

Urinalysis (Microscopy) Test Result

Tipo de datos

text

Alias
UMLS CUI [1]
C0430397
UMLS CUI [2]
C0587081
Laboratory Result Data (Haematology) - 24 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)
Descripción

Laboratory Result Data (Haematology) - 24 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
UMLS CUI-3
C0439568
Date and time sample taken (Haematology)
Descripción

Date and time sample taken (Haematology)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
UMLS CUI [1,4]
C0018941
Has the subject fasted?
Descripción

Has the subject fasted?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015663
Haematology Test - 24 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)
Descripción

Haematology Test - 24 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)

Alias
UMLS CUI-1
C0018941
Haematology Test
Descripción

Haematology Test

Tipo de datos

integer

Alias
UMLS CUI [1]
C0018941
Haematology Test Result
Descripción

Haematology Test Result

Tipo de datos

text

Alias
UMLS CUI [1]
C0018941
UMLS CUI [2]
C0587081
Urinalysis - 24 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)
Descripción

Urinalysis - 24 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0439568
Date and time sample taken (Urinalysis)
Descripción

Date and time sample taken (Urinalysis)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
UMLS CUI [2]
C0042014
Urinalysis (Dipstick) Test - 24 hrs (Treatment Period 1, 2, 3, 4, 5)
Descripción

Urinalysis (Dipstick) Test - 24 hrs (Treatment Period 1, 2, 3, 4, 5)

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0430370
Urinalysis (Dipstick) Test
Descripción

Urinalysis (Dipstick) Test

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0430370
Urinalysis (Dipstick) Test - 24 hrs (Treatment Period 1, 2, 3, 4, 5)
Descripción

Urinalysis (Dipstick) Test - 24 hrs (Treatment Period 1, 2, 3, 4, 5)

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0430370
Urinalysis (Dipstick) Test
Descripción

Urinalysis (Dipstick) Test

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0430370
Urinalysis (Dipstick) Test Result
Descripción

Urinalysis (Dipstick) Test Result

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0430370
UMLS CUI [2]
C0587081
Urinalysis (Microscopy) Test
Descripción

Urinalysis (Microscopy) Test

Tipo de datos

integer

Alias
UMLS CUI [1]
C0430397
Urinalysis (Microscopy) Test Result
Descripción

Urinalysis (Microscopy) Test Result

Tipo de datos

text

Alias
UMLS CUI [1]
C0430397
UMLS CUI [2]
C0587081
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Similar models

Laboratory Result Data; Urinalysis

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Laboratory Result data (Haematology) - 12 Hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
Date and time sample taken (Haematology)
Item
Date and time sample taken (Haematology)
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0018941 (UMLS CUI [1,4])
Has the subject fasted?
Item
Has the subject fasted?
boolean
C0015663 (UMLS CUI [1])
Item Group
Haematology Test (Treatment Period 1, 2, 3, 4, 5)
C0018941 (UMLS CUI-1)
Item
Haematology Test
integer
C0018941 (UMLS CUI [1])
Haematology Test
Code List
Haematology Test
CL Item
Hb (1)
CL Item
RBC (2)
CL Item
MCV (3)
CL Item
MCH (4)
CL Item
MCHC (5)
CL Item
Haematocrit (6)
CL Item
WBC (7)
CL Item
Neutrophils (8)
CL Item
Lymphocytes (9)
CL Item
Monocytes (10)
CL Item
Eosinophils (11)
CL Item
Basophils (12)
CL Item
Platelets (13)
Haematology Test Result
Item
Haematology Test Result
text
C0018941 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
Item Group
Urinalysis - 12 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)
C0042014 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
Date and time sample taken (Urinalysis)
Item
Date and time sample taken (Urinalysis)
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0042014 (UMLS CUI [2])
Item Group
Urinalysis (Dipstick) Test - 12 hrs (Treatment Period 1, 2, 3, 4, 5)
C0042014 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
Item
Urinalysis (Dipstick) Test
integer
C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Urinalysis (Dipstick) Test
Code List
Urinalysis (Dipstick) Test
CL Item
Protein (1)
CL Item
Blood (2)
CL Item
Ketones (3)
CL Item
Glucose (4)
CL Item
Bilirubin (5)
CL Item
Urobilinogen (6)
CL Item
Leukocyte esterase (7)
CL Item
Specific gravity (8)
CL Item
Nitrites (9)
CL Item
pH (10)
Urinalysis (Dipstick) Test Result
Item
Urinalysis (Dipstick) Test Result
text
C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0587081 (UMLS CUI [2])
Item
Urinalysis (Microscopy) Test
integer
C0430397 (UMLS CUI [1])
Urinalysis (Microscopy) Test
Code List
Urinalysis (Microscopy) Test
CL Item
WBC (1)
CL Item
RBC (2)
CL Item
Hyaline casts (3)
CL Item
Granular casts (4)
CL Item
Cellular casts (5)
Urinalysis (Microscopy) Test Result
Item
Urinalysis (Microscopy) Test Result
text
C0430397 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
Item Group
Laboratory Result Data (Haematology) - 24 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
Date and time sample taken (Haematology)
Item
Date and time sample taken (Haematology)
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0018941 (UMLS CUI [1,4])
Has the subject fasted?
Item
Has the subject fasted?
boolean
C0015663 (UMLS CUI [1])
Item Group
Haematology Test - 24 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)
C0018941 (UMLS CUI-1)
Item
Haematology Test
integer
C0018941 (UMLS CUI [1])
Haematology Test
Code List
Haematology Test
CL Item
Hb  (1)
CL Item
RBC  (2)
CL Item
MCV  (3)
CL Item
MCH  (4)
CL Item
MCHC  (5)
CL Item
Haematocrit  (6)
CL Item
WBC  (7)
CL Item
Neutrophils  (8)
CL Item
Lymphocytes  (9)
CL Item
Monocytes (10)
CL Item
Eosinophils (11)
CL Item
Basophils (12)
CL Item
Platelets (13)
Haematology Test Result
Item
Haematology Test Result
text
C0018941 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
Item Group
Urinalysis - 24 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)
C0042014 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
Date and time sample taken (Urinalysis)
Item
Date and time sample taken (Urinalysis)
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0042014 (UMLS CUI [2])
Item Group
Urinalysis (Dipstick) Test - 24 hrs (Treatment Period 1, 2, 3, 4, 5)
C0042014 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
Item
Urinalysis (Dipstick) Test
integer
C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Urinalysis (Dipstick) Test
Code List
Urinalysis (Dipstick) Test
CL Item
Protein  (1)
CL Item
Blood  (2)
CL Item
Ketones  (3)
CL Item
Glucose  (4)
CL Item
Bilirubin  (5)
CL Item
Urobilinogen  (6)
CL Item
Leukocyte esterase  (7)
CL Item
Specific gravity  (8)
CL Item
Nitrites  (9)
CL Item
pH (10)
Item Group
Urinalysis (Dipstick) Test - 24 hrs (Treatment Period 1, 2, 3, 4, 5)
C0042014 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
Item
Urinalysis (Dipstick) Test
integer
C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Urinalysis (Dipstick) Test
Code List
Urinalysis (Dipstick) Test
CL Item
Protein  (1)
CL Item
Blood  (2)
CL Item
Ketones  (3)
CL Item
Glucose  (4)
CL Item
Bilirubin  (5)
CL Item
Urobilinogen  (6)
CL Item
Leukocyte esterase  (7)
CL Item
Specific gravity  (8)
CL Item
Nitrites  (9)
CL Item
pH (10)
Urinalysis (Dipstick) Test Result
Item
Urinalysis (Dipstick) Test Result
text
C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0587081 (UMLS CUI [2])
Item
Urinalysis (Microscopy) Test
integer
C0430397 (UMLS CUI [1])
Urinalysis (Microscopy) Test
Code List
Urinalysis (Microscopy) Test
CL Item
WBC  (1)
CL Item
RBC  (2)
CL Item
Hyaline casts  (3)
CL Item
Granular casts  (4)
CL Item
Cellular casts (5)
Urinalysis (Microscopy) Test Result
Item
Urinalysis (Microscopy) Test Result
text
C0430397 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
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