ID
40803
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 during Treatment Period 2. Planned Timepoint: Day 1. Record any changes to the subject’s concomitant medications or any new medications taken since the last visit in the appropriate Concomitant Medications section. Review adverse events at 4 and 12 hours post-dose, in addition to any spontaneously reported AEs throughout the day. Record details of any new adverse events observed or reported by the subject or any changes to ongoing adverse events in the appropriate Non-Serious Adverse Events/Serious Adverse Event section.
Trefwoorden
Versies (1)
- 15-05-20 15-05-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
15 mei 2020
DOI
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Licentie
Creative Commons BY-NC 4.0
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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933
Oral dose, Treatment Confirmation
- StudyEvent: ODM
Beschrijving
Investigational Product - Oral Dose Administration
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C1527415
Beschrijving
Fasting
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015663
Beschrijving
Specification of quantities and time of food consumption
Datatype
text
Alias
- UMLS CUI [1,1]
- C2983605
- UMLS CUI [1,2]
- C1265611
- UMLS CUI [2,1]
- C2983605
- UMLS CUI [2,2]
- C0040223
Beschrijving
Date of dose
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Beschrijving
Time of dose
Datatype
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0040223
Beschrijving
Treatment Confirmation
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C0750484
Beschrijving
Therapeutic Procedure, Confirmation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C0750484
Beschrijving
Therapeutic Procedure, Wrong, Reason and justification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C3827420
- UMLS CUI [1,3]
- C0566251
Similar models
Oral dose, Treatment Confirmation
- StudyEvent: ODM
C1527415 (UMLS CUI-2)
C1265611 (UMLS CUI [1,2])
C2983605 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0750484 (UMLS CUI-2)
C0750484 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])