0 Ratings
ID

32736

Description

Study ID: 109059 Clinical Study ID: OTB109059 Study Title: TXA107979:A Phase II Study to Evaluate: Delay in Intravaginal Ejaculatory Latency Time (IELT), Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Randomized, Double Blind, Placebo-Controlled, Parallel Group Study in Men with Premature Ejaculation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01021553 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: epelsiban Trade Name: Study Indication: Premature Ejaculation

Keywords

Versions (1)
  1. 11/13/18 11/13/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 13, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059

    English

    Pharmacokinetics

    1 forms  
    1. StudyEvent: ODM
      1. Pharmacokinetics
    Pharmacokinetics
    Description

    Pharmacokinetics

    Alias
    UMLS CUI-1
    C0031328 (Pharmacokinetic aspects)
    Was a pharmacokinetic blood sample obtained?
    Description

    Pharmacokinetic aspects, Blood, Sampling

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0031328 (Pharmacokinetic aspects)
    UMLS CUI [1,2]
    C0005767 (Blood)
    SNOMED
    87612001
    LOINC
    LP71680-0
    UMLS CUI [1,3]
    C0870078 (Sampling)
    Date and time sample taken
    Description

    Pharmacokinetic aspects, Blood, Sampling, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328 (Pharmacokinetic aspects)
    UMLS CUI [1,2]
    C0005767 (Blood)
    SNOMED
    87612001
    LOINC
    LP71680-0
    UMLS CUI [1,3]
    C0870078 (Sampling)
    UMLS CUI [1,4]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,5]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Date and time of last investigational product dose prior to PK sample
    Description

    Pharmacokinetic aspects, Blood, Experimental drug, Date last dose, Time last dose

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328 (Pharmacokinetic aspects)
    UMLS CUI [1,2]
    C0005767 (Blood)
    SNOMED
    87612001
    LOINC
    LP71680-0
    UMLS CUI [1,3]
    C0304229 (Experimental drug)
    UMLS CUI [1,4]
    C1762893 (Date last dose)
    LOINC
    LP29043-4
    UMLS CUI [1,5]
    C0946444 (Time last dose)
    LOINC
    LP29120-0
    Sample Identifier
    Description

    Pharmacokinetic aspects, Blood, Sample Identification Number

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328 (Pharmacokinetic aspects)
    UMLS CUI [1,2]
    C0005767 (Blood)
    SNOMED
    87612001
    LOINC
    LP71680-0
    UMLS CUI [1,3]
    C1299222 (Sample identification number)
    SNOMED
    372274003
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    Similar models

    Pharmacokinetics

    1 forms
    1. StudyEvent: ODM
      1. Pharmacokinetics
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Pharmacokinetics
    C0031328 (UMLS CUI-1)
    Pharmacokinetic aspects, Blood, Sampling
    Item
    Was a pharmacokinetic blood sample obtained?
    boolean
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    Pharmacokinetic aspects, Blood, Sampling, Date in time, Time
    Item
    Date and time sample taken
    datetime
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    C0040223 (UMLS CUI [1,5])
    Pharmacokinetic aspects, Blood, Experimental drug, Date last dose, Time last dose
    Item
    Date and time of last investigational product dose prior to PK sample
    datetime
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [1,3])
    C1762893 (UMLS CUI [1,4])
    C0946444 (UMLS CUI [1,5])
    Pharmacokinetic aspects, Blood, Sample Identification Number
    Item
    Sample Identifier
    datetime
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C1299222 (UMLS CUI [1,3])
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