ID
40798
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. The Continuous 12-Lead ECG Form has to be filled in during Treatment Period 1.
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
Continuous 12-Lead ECG
- StudyEvent: ODM
Description
Continuous 12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0549178
Description
Continuous 12-Lead ECG start date
Data type
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [1,3]
- C0808070
Description
Continuous 12-Lead ECG start time
Data type
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [1,3]
- C1301880
Description
Continuous 12-Lead ECG end time
Data type
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [1,3]
- C1522314
Description
Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete additional ECG Abnormalities page if clinically significant abnormalities are present.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [1,3]
- C1274040
Similar models
Continuous 12-Lead ECG
- StudyEvent: ODM
C0549178 (UMLS CUI-2)
C0549178 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])