ID
40802
Descripción
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
Palabras clave
Versiones (1)
- 15/5/20 15/5/20 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
15 de mayo de 2020
DOI
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Licencia
Creative Commons BY-NC 4.0
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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933
Randomisation number, IV dose, Treatment Confirmation
- StudyEvent: ODM
Descripción
Randomisation Number
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Descripción
Investigational Product - IV Dosing
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0678766
- UMLS CUI-3
- C0348016
Descripción
Infusion Start Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0439659
Descripción
Infusion Start Time
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0439659
- UMLS CUI [1,3]
- C0040223
Descripción
Infusion Stop Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0574032
Descripción
Infusion Stop Time
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0574032
Descripción
Fasting
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0015663
Descripción
Specification of quantities and time of food consumption
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2983605
- UMLS CUI [1,2]
- C1265611
- UMLS CUI [2,1]
- C2983605
- UMLS CUI [2,2]
- C0040223
Descripción
Treatment Confirmation
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C0750484
Descripción
Therapeutic Procedure, Confirmation
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C0750484
Descripción
Therapeutic Procedure, Wrong, Reason and justification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C3827420
- UMLS CUI [1,3]
- C0566251
Similar models
Randomisation number, IV dose, Treatment Confirmation
- StudyEvent: ODM
C0237753 (UMLS CUI [1,2])
C0678766 (UMLS CUI-2)
C0348016 (UMLS CUI-3)
C0574032 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0574032 (UMLS CUI [1,2])
C0574032 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,2])
C2983605 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0750484 (UMLS CUI-2)
C0750484 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])