ID
41004
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. The Physical Examination Form is used to record the physical examination at screening visit.
Keywords
Versions (1)
- 6/10/20 6/10/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
June 10, 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
Physical Examination
- StudyEvent: ODM
Description
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Description
Physical Examination Date
Data type
date
Alias
- UMLS CUI [1]
- C2826643
Description
Physical examination Hair | Physical examination Skin
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0018494
- UMLS CUI [2,1]
- C0031809
- UMLS CUI [2,2]
- C1123023
Description
Physical examination Hair Description | Physical examination Skin Description
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0018494
- UMLS CUI [1,3]
- C0678257
- UMLS CUI [2,1]
- C0031809
- UMLS CUI [2,2]
- C1123023
- UMLS CUI [2,3]
- C0678257
Description
Physical examination Lymph nodes
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024204
Description
Physical examination Lymph nodes Description
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024204
- UMLS CUI [1,3]
- C0678257
Description
Physical examination Eyes
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0015392
Description
Physical examination Eyes Description
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0015392
- UMLS CUI [1,3]
- C0678257
Description
Physical examination ENT
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0278350
Description
Physical examination ENT Description
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0278350
- UMLS CUI [1,3]
- C0678257
Description
Physical examination Breasts
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0199850
Description
Physical Examination Breasts Description
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0199850
- UMLS CUI [1,3]
- C0678257
Description
Physical examination Respiratory
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0035237
Description
Physical examination Respiratory Description
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0035237
- UMLS CUI [1,3]
- C0678257
Description
Physical examination Cardiovascular
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0007226
Description
Physical examination Cardiovascular Description
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0007226
- UMLS CUI [1,3]
- C0678257
Description
Physical examination Abdomen
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0000726
Description
Physical examination Abdomen Description
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0000726
- UMLS CUI [1,3]
- C0678257
Description
Physical examination Urogenital
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C1828035
Description
Physical examination Urogenital Description
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C1828035
- UMLS CUI [1,3]
- C0678257
Description
Physical examination Pelvis
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0030797
Description
Physical examination Pelvis Description
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0030797
- UMLS CUI [1,3]
- C0678257
Description
Physical examination Rectal
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0199900
Description
Physical examination Rectal Description
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0199900
- UMLS CUI [1,3]
- C0678257
Description
Physical examination Musculoskeletal
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0026860
Description
Physical examination Musculoskeletal Description
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0026860
- UMLS CUI [1,3]
- C0678257
Description
Physical examination Neurological
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0027853
Description
Physical Examination Neurological Description
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0027853
- UMLS CUI [1,3]
- C0678257
Description
Physical examination Mental status
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0278060
Description
Physical examination Mental status Description
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0278060
- UMLS CUI [1,3]
- C0678257
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Physical Examination
- StudyEvent: ODM
C0018494 (UMLS CUI [1,2])
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C1123023 (UMLS CUI [2,2])
C0018494 (UMLS CUI [1,2])
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C1123023 (UMLS CUI [2,2])
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C0035237 (UMLS CUI [1,2])
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C0278060 (UMLS CUI [1,2])
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