ID
40851
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. This Form confirms the accuracy of data by the Investigator and provides further comments. It has to be filled after the Screening and after Subject's participation in the study has ended.
Palavras-chave
Versões (1)
- 26/05/2020 26/05/2020 -
Titular dos direitos
GlaxoSmithKline
Transferido a
26 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
Investigator Comment Log, Investigator's Signature
- StudyEvent: ODM
Descrição
Investigator Comment Log
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C0947611
Descrição
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Descrição
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Tipo de dados
text
Alias
- UMLS CUI [1]
- C2346576
Descrição
Investigator's name
Tipo de dados
text
Alias
- UMLS CUI [1]
- C2826892
Descrição
Investigator's signature: Date
Tipo de dados
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
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Investigator Comment Log, Investigator's Signature
- StudyEvent: ODM
C0947611 (UMLS CUI-2)
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