ID

26662

Descrição

Study ID: 100690 Clinical Study ID: NKP100690 Study Title: A randomised, double blind triple dummy, placebo controlled balanced incomplete block crossover study to evaluate the change in response to a 7% CO2 challenge and pharmacokinetics of single oral doses of GW597599 and paroxetine (5 or 7.5 mg) either alone or in combination, or alprazolam (0.75 mg) in healthy volunteers 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: paroxetine Trade Name: Tagonis,Seroxat,Paxil,Paroxat,Deroxat,Aropax Study Indication: Depressive Disorder and Anxiety Disorders CRF Seiten: 255-365

Palavras-chave

  1. 23/10/2017 23/10/2017 -
Titular dos direitos

GSK

Transferido a

23 de outubro de 2017

DOI

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Licença

Creative Commons BY-NC 3.0

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7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690

Follow-Up Unscheduled

  1. StudyEvent: ODM
    1. Follow-Up Unscheduled
Administrative Documentation
Descrição

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Descrição

Subject Number

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Ensure a blood sample has been taken tor clinical chemistry and haematology
Descrição

Ensure a blood sample has been taken tor clinical chemistry and haematology

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0018941
Exact date and time of blood sampling
Descrição

Date | Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0005834
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C0040223
Comments
Descrição

Comment

Tipo de dados

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Adverse Event page.
Descrição

Abnormal finding

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C2826633
UMLS CUI [2,1]
C0474523
UMLS CUI [2,2]
C2826633
Ensure a urine sample has been taken for urinalysis
Descrição

Ensure a urine sample has been taken for urinalysis

Alias
UMLS CUI-1
C0042014
Exact date and time of urine sampling
Descrição

Date | Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0200354
UMLS CUI [2,2]
C0040223
Comments
Descrição

Comment

Tipo de dados

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Adverse Event page.
Descrição

Abnormal Finding

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C2826633

Similar models

Follow-Up Unscheduled

  1. StudyEvent: ODM
    1. Follow-Up Unscheduled
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Ensure a blood sample has been taken tor clinical chemistry and haematology
C0008000 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
Date | Time
Item
Exact date and time of blood sampling
datetime
C0005834 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
Comment
Item
Comments
text
C0947611 (UMLS CUI [1])
Abnormal finding
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Adverse Event page.
boolean
C0008000 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
C0474523 (UMLS CUI [2,1])
C2826633 (UMLS CUI [2,2])
Item Group
Ensure a urine sample has been taken for urinalysis
C0042014 (UMLS CUI-1)
Date | Time
Item
Exact date and time of urine sampling
datetime
C0200354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0200354 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
Comment
Item
Comments
text
C0947611 (UMLS CUI [1])
Abnormal Finding
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Adverse Event page.
boolean
C0042014 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])

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