ID

40802

Descrição

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A 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 Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. This form has to be filled in during Treatment Period 1. Planned Timepoint: Day 1

Palavras-chave

Versões (1)
  1. 15/05/2020 15/05/2020 -
Titular dos direitos

GlaxoSmithKline

Transferido a

15 de maio de 2020

DOI

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Licença

Creative Commons BY-NC 4.0
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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933

Inglês

Randomisation number, IV dose, Treatment Confirmation

1 Formulários  
Administrative Data
Descrição

Administrative Data

Subject Identifier
Descrição

Subject Identifier

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Descrição

Visit Date

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
Randomisation Number
Descrição

Randomisation Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Randomisation Number
Descrição

Randomisation Number

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Investigational Product - IV Dosing
Descrição

Investigational Product - IV Dosing

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0678766
UMLS CUI-3
C0348016
Infusion Start Date
Descrição

Infusion Start Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0574032
UMLS CUI [1,3]
C0439659
Infusion Start Time
Descrição

Infusion Start Time

Tipo de dados

time

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C0040223
Infusion Stop Date
Descrição

Infusion Stop Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0574032
Infusion Stop Time
Descrição

Infusion Stop Time

Tipo de dados

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0574032
Did the subject fast per protocol?
Descrição

Fasting

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0015663
If NO, specify time and quantities that were consumed:
Descrição

Specification of quantities and time of food consumption

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2983605
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C2983605
UMLS CUI [2,2]
C0040223
Treatment Confirmation
Descrição

Treatment Confirmation

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0750484
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Descrição

Therapeutic Procedure, Confirmation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0750484
If No, record reason(s)
Descrição

Therapeutic Procedure, Wrong, Reason and justification

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3827420
UMLS CUI [1,3]
C0566251
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Similar models

Randomisation number, IV dose, Treatment Confirmation

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Data
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Investigational Product - IV Dosing
C0304229 (UMLS CUI-1)
C0678766 (UMLS CUI-2)
C0348016 (UMLS CUI-3)
Infusion Start Date
Item
Infusion Start Date
date
C0011008 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
Infusion Start Time
Item
Infusion Start Time
time
C0574032 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Infusion Stop Date
Item
Infusion Stop Date
date
C0806020 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
Infusion Stop Time
Item
Infusion Stop Time
time
C1522314 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
Fasting
Item
Did the subject fast per protocol?
boolean
C0015663 (UMLS CUI [1])
Specification of quantities and time of food consumption
Item
If NO, specify time and quantities that were consumed:
text
C2983605 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2983605 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
Item Group
Treatment Confirmation
C0087111 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
Therapeutic Procedure, Confirmation
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
Therapeutic Procedure, Wrong, Reason and justification
Item
If No, record reason(s)
text
C0087111 (UMLS CUI [1,1])
C3827420 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Voltar ao início da página 

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