ID

44003

Description

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

Keywords

Versions (2)
  1. 10/18/17 10/18/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

GSK

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0
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7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690

English

Screening; Prior Medication

1 forms  
Administrative Documentation
Description

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Prior Medication
Description

Prior Medication

Alias
UMLS CUI-1
C2826257
Has the subject taken any medication within 1 week PRIOR to the first dose of study medication? If 'YES', please record the medications below.
Description

Prior medication

Data type

boolean

Alias
UMLS CUI [1]
C2826257
Prior Medication
Description

Prior Medication

Alias
UMLS CUI-1
C2826257
Drug Name (Trade Name Preferred)
Description

Drug Name

Data type

text

Alias
UMLS CUI [1]
C0013227
SINGLE Dose/Unit
Description

Drug Dosage

Data type

text

Alias
UMLS CUI [1]
C0870450
Frequency of this Dose (e.g. BID, PRN)
Description

Frequency

Data type

text

Alias
UMLS CUI [1]
C3476109
Route
Description

Administration Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Indication
Description

Indication

Data type

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Duration of therapy (e.g. 6 years)
Description

Therapy duration

Data type

text

Alias
UMLS CUI [1]
C0444921
End Date
Description

End Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Continuing at end of study?
Description

Continuing medication

Data type

boolean

Alias
UMLS CUI [1]
C2826666
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Similar models

Screening; Prior Medication

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Prior Medication
C2826257 (UMLS CUI-1)
Prior medication
Item
Has the subject taken any medication within 1 week PRIOR to the first dose of study medication? If 'YES', please record the medications below.
boolean
C2826257 (UMLS CUI [1])
Item Group
Prior Medication
C2826257 (UMLS CUI-1)
Drug Name
Item
Drug Name (Trade Name Preferred)
text
C0013227 (UMLS CUI [1])
Drug Dosage
Item
SINGLE Dose/Unit
text
C0870450 (UMLS CUI [1])
Frequency
Item
Frequency of this Dose (e.g. BID, PRN)
text
C3476109 (UMLS CUI [1])
Administration Route
Item
Route
text
C0013153 (UMLS CUI [1])
Indication
Item
Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Therapy duration
Item
Duration of therapy (e.g. 6 years)
text
C0444921 (UMLS CUI [1])
End Date
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Continuing medication
Item
Continuing at end of study?
boolean
C2826666 (UMLS CUI [1])
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