ID
40843
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. The Concomitant Medications has to be filled in at the Screening Visit and throughout the study whenever a change in patient's medication is made.
Trefwoorden
Versies (1)
- 24-05-20 24-05-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
24 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
Concomitant Medications
- StudyEvent: ODM
Beschrijving
Concomintant Medications
Alias
- UMLS CUI-1
- C2347852
Beschrijving
If Yes, record each medication on a separate line using Trade Names where possible. If the medication is related to a Non-Serious Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Beschrijving
List of Concomintant Medications
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Concomitant Agent Drug Name
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Beschrijving
Concomitant Agent Unit Dose
Datatype
float
Alias
- UMLS CUI [1]
- C2826646
Beschrijving
Concomitant Agent Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0439148
Beschrijving
Concomitant Agent Frequency
Datatype
text
Alias
- UMLS CUI [1]
- C2826654
Beschrijving
Concomitant Agent Drug Administration Routes
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0013153
Beschrijving
Concomitant Agent Indication
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C3146298
Beschrijving
Concomitant Agent Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826734
Beschrijving
Concomitant Agent Start Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1301880
Beschrijving
Concomitant Agent Taken Prior to Study?
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826667
Beschrijving
Concomitant Agent Stop Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826744
Beschrijving
Concomitant Agent Stop Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1522314
Beschrijving
Concomitant Agent Ongoing
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826666
Similar models
Concomitant Medications
- StudyEvent: ODM
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C2360065 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])