ID
40850
Beschrijving
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 at the subject completion or withdrawal from the study.
Trefwoorden
Versies (1)
- 26-05-20 26-05-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
26 mei 2020
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 4.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933
Study Conclusion, Pregnancy Information
- StudyEvent: ODM
Beschrijving
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
Beschrijving
Date of subject completion or withdrawal
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0422727
- UMLS CUI [2]
- C1549507
Beschrijving
Was the subject withdrawn from the study?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0422727
Beschrijving
If the reason was an adverse event, record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1549995
Beschrijving
Other reason for withdrawal, specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C1521902
Beschrijving
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Similar models
Study Conclusion, Pregnancy Information
- StudyEvent: ODM
C0422727 (UMLS CUI [1,2])
C1549507 (UMLS CUI [2])
C1549995 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C3828490 (UMLS CUI [1,2])