ID

41003

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 Medical Conditions Form is used to record current and past medical conditions at screening visit.

Keywords

Versions (1)
  1. 6/10/20 6/10/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 10, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933

English

Medical Conditions

1 forms  
  1. StudyEvent: ODM
    1. Medical Conditions
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Medical Conditions
Description

Medical Conditions

Alias
UMLS CUI-1
C0012634
Diagnosis
Description

Only in the absence of a diagnosis, record the signs and symptoms on separate lines

Data type

text

Alias
UMLS CUI [1]
C0011900
Diagnosis status
Description

Diagnosis status

Data type

integer

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0449438
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Similar models

Medical Conditions

1 forms
  1. StudyEvent: ODM
    1. Medical Conditions
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Medical Conditions
C0012634 (UMLS CUI-1)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item
Diagnosis status
integer
C0011900 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Diagnosis status
Code List
Diagnosis status
CL Item
Current (1)
CL Item
Past (2)
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