ID
40802
Description
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
Keywords
Versions (1)
- 5/15/20 5/15/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 15, 2020
DOI
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License
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
Description
Randomisation Number
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Description
Investigational Product - IV Dosing
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0678766
- UMLS CUI-3
- C0348016
Description
Infusion Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0439659
Description
Infusion Start Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0439659
- UMLS CUI [1,3]
- C0040223
Description
Infusion Stop Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0574032
Description
Infusion Stop Time
Data type
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0574032
Description
Fasting
Data type
boolean
Alias
- UMLS CUI [1]
- C0015663
Description
Specification of quantities and time of food consumption
Data type
text
Alias
- UMLS CUI [1,1]
- C2983605
- UMLS CUI [1,2]
- C1265611
- UMLS CUI [2,1]
- C2983605
- UMLS CUI [2,2]
- C0040223
Description
Treatment Confirmation
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C0750484
Description
Therapeutic Procedure, Confirmation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C0750484
Description
Therapeutic Procedure, Wrong, Reason and justification
Data type
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])