ID
40843
Beschreibung
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.
Stichworte
Versionen (1)
- 24.05.20 24.05.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
24. Mai 2020
DOI
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Lizenz
Creative Commons BY-NC 4.0
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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933
Concomitant Medications
- StudyEvent: ODM
Beschreibung
Concomintant Medications
Alias
- UMLS CUI-1
- C2347852
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Beschreibung
List of Concomintant Medications
Alias
- UMLS CUI-1
- C2347852
Beschreibung
Concomitant Agent Drug Name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Beschreibung
Concomitant Agent Unit Dose
Datentyp
float
Alias
- UMLS CUI [1]
- C2826646
Beschreibung
Concomitant Agent Unit
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0439148
Beschreibung
Concomitant Agent Frequency
Datentyp
text
Alias
- UMLS CUI [1]
- C2826654
Beschreibung
Concomitant Agent Drug Administration Routes
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0013153
Beschreibung
Concomitant Agent Indication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C3146298
Beschreibung
Concomitant Agent Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2826734
Beschreibung
Concomitant Agent Start Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1301880
Beschreibung
Concomitant Agent Taken Prior to Study?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826667
Beschreibung
Concomitant Agent Stop Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2826744
Beschreibung
Concomitant Agent Stop Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1522314
Beschreibung
Concomitant Agent Ongoing
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Ähnliche Modelle
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])