ID
40799
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. The Vital Signs Form has to be filled in at following visits: Screening, Treatment Period 1 Predose, Treatment Period 1 Prior to Discharge, Treatment Period 2 Predose, Treatment Period 2 Prior to Discharge, and whenever further assesments are done during the study (Unscheduled).
Palavras-chave
Versões (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
Vital Signs
- StudyEvent: ODM
Descrição
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Descrição
Vital Signs; Date
Tipo de dados
date
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0011008
Descrição
Vital Signs; Time
Tipo de dados
time
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0040223
Descrição
Blood Pressure Systolic
Tipo de dados
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Descrição
Blood Pressure Diastolic
Tipo de dados
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Descrição
Heart Rate
Tipo de dados
integer
Unidades de medida
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Descrição
To be filled in only at screening visit. First measurement in semi-supine position, second measurement in standing position. Body position should be semi-supine at all other visits.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1262869
Similar models
Vital Signs
- StudyEvent: ODM
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])