ID

25735

Description

Dosing regime - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876 Study ID: 100789 Clinical Study ID: NKV100789 Study Title: A two-part, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of single intravenous doses of GW679769 when administered alone and in combination with intravenous or oral doses of dexamethasone in healthy adult subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00291876 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Keywords

Versions (1)
  1. 9/16/17 9/16/17 -
Copyright Holder

glaxoSmithKline

Uploaded on

September 16, 2017

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Creative Commons BY-NC 3.0
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Dosing regime - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876

English

Dosing regime - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876

1 forms  
Regime selection
Description

Regime selection

Alias
UMLS CUI-1
C0013153
UMLS CUI-2
C0679006
Please select a regime for this subject and this session and press "continue".
Description

drug administration regime decision

Data type

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0679006
Study medication oral
Description

Study medication oral

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0304229
UMLS CUI-3
C1527415
Session day
Description

Dosing day

Data type

partialDate

Alias
UMLS CUI [1,1]
C1883016
UMLS CUI [1,2]
C0439228
Session hour
Description

Session hour

Data type

partialDatetime

Alias
UMLS CUI [1,1]
C1883016
UMLS CUI [1,2]
C0439227
Session minute
Description

Session minute

Data type

partialDatetime

Alias
UMLS CUI [1,1]
C1883016
UMLS CUI [1,2]
C0439232
Start Dose Date
Description

Start dose date

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0178602
Start Dose Time
Description

Start dose time

Data type

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0178602
Dose amount
Description

Dose amount

Data type

integer

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264637
Dose units
Description

Dose unit

Data type

text

Alias
UMLS CUI [1]
C0869039
Dose formulation
Description

Dose form

Data type

text

Alias
UMLS CUI [1]
C0013058
Dose route
Description

Dose route

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0679006
Study Medication IV
Description

Study Medication IV

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0304229
UMLS CUI-3
C1522726
Session day
Description

Dosing day

Data type

partialDate

Alias
UMLS CUI [1,1]
C1883016
UMLS CUI [1,2]
C0439228
Session hour
Description

Session hour

Data type

partialDatetime

Alias
UMLS CUI [1,1]
C1883016
UMLS CUI [1,2]
C0439227
Session minute
Description

Session minute

Data type

partialDatetime

Alias
UMLS CUI [1,1]
C1883016
UMLS CUI [1,2]
C0439232
Start Dose Date
Description

Start dose date

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0178602
Start Dose Time
Description

Start dose time

Data type

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0178602
End Dose Date
Description

End Dose Date

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0178602
End Dose Time
Description

End Dose Time

Data type

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0178602
Start Dose Volume
Description

Start Dose Volume

Data type

text

Alias
UMLS CUI [1,1]
C0449468
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0439659
End Dose Volume
Description

End Dose Volume

Data type

text

Alias
UMLS CUI [1,1]
C0449468
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0444930
Dose amount
Description

Dose amount

Data type

integer

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264637
Dose units
Description

Dose unit

Data type

text

Alias
UMLS CUI [1]
C0869039
Dose formulation
Description

Dose form

Data type

text

Alias
UMLS CUI [1]
C0013058
Dose route
Description

Dose route

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0679006
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Similar models

Dosing regime - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Regime selection
C0013153 (UMLS CUI-1)
C0679006 (UMLS CUI-2)
Item
Please select a regime for this subject and this session and press "continue".
integer
C0013153 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
undefined item
Code List
Please select a regime for this subject and this session and press "continue".
CL Item
O-Single 150mg Oral of GW679769 (1)
CL Item
P-Placebo for IV GW679769 (2)
CL Item
X1-IV GW679769 12mg (3)
CL Item
X2-IV GW679769 12-35mg (4)
CL Item
X3-IV GW679769 35-70mg (5)
CL Item
X4-IV GW679769 70-130mg (6)
Item Group
Study medication oral
C0013227 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C1527415 (UMLS CUI-3)
Dosing day
Item
Session day
partialDate
C1883016 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Session hour
Item
Session hour
partialDatetime
C1883016 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
Session minute
Item
Session minute
partialDatetime
C1883016 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
Start dose date
Item
Start Dose Date
date
C0808070 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Start dose time
Item
Start Dose Time
time
C1301880 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Dose amount
Item
Dose amount
integer
C0178602 (UMLS CUI [1,1])
C1264637 (UMLS CUI [1,2])
Dose unit
Item
Dose units
text
C0869039 (UMLS CUI [1])
Dose form
Item
Dose formulation
text
C0013058 (UMLS CUI [1])
Dose route
Item
Dose route
text
C0013153 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Item Group
Study Medication IV
C0013227 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C1522726 (UMLS CUI-3)
Dosing day
Item
Session day
partialDate
C1883016 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Session hour
Item
Session hour
partialDatetime
C1883016 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
Session minute
Item
Session minute
partialDatetime
C1883016 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
Start dose date
Item
Start Dose Date
date
C0808070 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Start dose time
Item
Start Dose Time
time
C1301880 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
End Dose Date
Item
End Dose Date
date
C0806020 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
End Dose Time
Item
End Dose Time
time
C1522314 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Start Dose Volume
Item
Start Dose Volume
text
C0449468 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
End Dose Volume
Item
End Dose Volume
text
C0449468 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
Dose amount
Item
Dose amount
integer
C0178602 (UMLS CUI [1,1])
C1264637 (UMLS CUI [1,2])
Dose unit
Item
Dose units
text
C0869039 (UMLS CUI [1])
Dose form
Item
Dose formulation
text
C0013058 (UMLS CUI [1])
Dose route
Item
Dose route
text
C0013153 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
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