0 Ratings

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

  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

    Medical Conditions

    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

    Similar models

    Medical Conditions

    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])
    Code List
    Diagnosis status
    CL Item
    Current (1)
    CL Item
    Past (2)

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