ID
40802
Beskrivning
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
Nyckelord
Versioner (1)
- 2020-05-15 2020-05-15 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
15 maj 2020
DOI
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Licens
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
Beskrivning
Randomisation Number
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Beskrivning
Investigational Product - IV Dosing
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0678766
- UMLS CUI-3
- C0348016
Beskrivning
Infusion Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0439659
Beskrivning
Infusion Start Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0439659
- UMLS CUI [1,3]
- C0040223
Beskrivning
Infusion Stop Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0574032
Beskrivning
Infusion Stop Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0574032
Beskrivning
Fasting
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015663
Beskrivning
Specification of quantities and time of food consumption
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2983605
- UMLS CUI [1,2]
- C1265611
- UMLS CUI [2,1]
- C2983605
- UMLS CUI [2,2]
- C0040223
Beskrivning
Treatment Confirmation
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C0750484
Beskrivning
Therapeutic Procedure, Confirmation
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C0750484
Beskrivning
Therapeutic Procedure, Wrong, Reason and justification
Datatyp
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])