ID
40803
Description
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.
Keywords
Versions (1)
- 5/15/20 5/15/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 15, 2020
DOI
To request one please log in.
License
Creative Commons BY-NC 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933
Oral dose, Treatment Confirmation
- StudyEvent: ODM
Description
Investigational Product - Oral Dose Administration
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C1527415
Description
Fasting
Data type
boolean
Alias
- UMLS CUI [1]
- C0015663
Description
Specification of quantities and time of food consumption
Data type
text
Alias
- UMLS CUI [1,1]
- C2983605
- UMLS CUI [1,2]
- C1265611
- UMLS CUI [2,1]
- C2983605
- UMLS CUI [2,2]
- C0040223
Description
Date of dose
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Description
Time of dose
Data type
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0040223
Description
Treatment Confirmation
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C0750484
Description
Therapeutic Procedure, Confirmation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C0750484
Description
Therapeutic Procedure, Wrong, Reason and justification
Data type
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])