0 Evaluaciones

ID

33733

Descripción

Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Palabras clave

  1. 21/12/18 21/12/18 -
Titular de derechos de autor

GSK group of companies

Subido en

21 dicembre 2018

DOI

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Licencia

Creative Commons BY-NC 3.0

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    Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032

    Period 1 Day 11 (Visit 90): Vital Signs, Pharmacogenetics, Pharmacodynamics, Drug Admission

    Administrative data
    Descripción

    Administrative data

    Site
    Descripción

    Site

    Tipo de datos

    text

    Subject
    Descripción

    Subject

    Tipo de datos

    text

    Visit Name
    Descripción

    Visit Name

    Tipo de datos

    text

    Status
    Descripción

    Status

    Tipo de datos

    text

    Doc №
    Descripción

    Doc №

    Tipo de datos

    integer

    Is Page Blank?
    Descripción

    blank page?

    Tipo de datos

    boolean

    Visit Date
    Descripción

    Visit Date

    Tipo de datos

    date

    Admission Criteria
    Descripción

    Admission Criteria

    Protocol Date
    Descripción

    Protocol Date

    Tipo de datos

    date

    Does the subject continue to meet all eligibility criteria?
    Descripción

    Does the subject continue to meet all eligibility criteria?

    Tipo de datos

    boolean

    Study Drug Administration
    Descripción

    Study Drug Administration

    Drug Name
    Descripción

    Drug Name

    Tipo de datos

    text

    Was the dose administered?
    Descripción

    Was the dose administered?

    Tipo de datos

    boolean

    Dose Date
    Descripción

    Dose Date

    Tipo de datos

    date

    Dose Time
    Descripción

    Dose Time

    Tipo de datos

    time

    Dose
    Descripción

    e.g., 0.5/0.035

    Tipo de datos

    text

    Unit
    Descripción

    e.g., mg

    Tipo de datos

    text

    Comment
    Descripción

    Comment

    Tipo de datos

    text

    Pharmacogenetic Blood Collection
    Descripción

    Pharmacogenetic Blood Collection

    Was the sample collected?
    Descripción

    Was the sample collected?

    Tipo de datos

    boolean

    Timepoint
    Descripción

    Timepoint

    Tipo de datos

    text

    Sample Date
    Descripción

    Sample Date

    Tipo de datos

    date

    Sample Time
    Descripción

    Sample Time

    Tipo de datos

    time

    Comment
    Descripción

    Comment

    Tipo de datos

    text

    Vital Signs
    Descripción

    Vital Signs

    Date of Vital Signs
    Descripción

    Date of Vital Signs

    Tipo de datos

    date

    Duplicate Number
    Descripción

    Duplicate Number

    Tipo de datos

    integer

    Time
    Descripción

    Time

    Tipo de datos

    time

    Blood Pressure - Systolic
    Descripción

    Blood Pressure - Systolic

    Tipo de datos

    float

    Unidades de medida
    • mmHg
    mmHg
    Blood Pressure - Diastolic
    Descripción

    Blood Pressure - Diastolic

    Tipo de datos

    float

    Unidades de medida
    • mmHg
    mmHg
    Heart Rate
    Descripción

    Heart Rate

    Tipo de datos

    integer

    Unidades de medida
    • bpm
    bpm
    Temperature
    Descripción

    Temperature

    Tipo de datos

    float

    Unidades de medida
    • °C
    °C
    Body Position
    Descripción

    e.g., Sitting

    Tipo de datos

    text

    Comment
    Descripción

    Comment

    Tipo de datos

    text

    Pharmacodynamic Blood Collection
    Descripción

    Pharmacodynamic Blood Collection

    Was the sample collected?
    Descripción

    Was the sample collected?

    Tipo de datos

    boolean

    Hormone
    Descripción

    Hormone

    Tipo de datos

    text

    Timepoint
    Descripción

    Timepoint

    Tipo de datos

    text

    Sample Date
    Descripción

    Sample Date

    Tipo de datos

    date

    Sample Time
    Descripción

    Sample Time

    Tipo de datos

    time

    Comment
    Descripción

    Comment

    Tipo de datos

    text

    Similar models

    Period 1 Day 11 (Visit 90): Vital Signs, Pharmacogenetics, Pharmacodynamics, Drug Admission

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative data
    Site
    Item
    Site
    text
    Subject
    Item
    Subject
    text
    Item
    Visit Name
    text
    Code List
    Visit Name
    CL Item
    Period 1 Day 11 (1)
    Status
    Item
    Status
    text
    Doc №
    Item
    Doc №
    integer
    blank page?
    Item
    Is Page Blank?
    boolean
    Visit Date
    Item
    Visit Date
    date
    Item Group
    Admission Criteria
    Protocol Date
    Item
    Protocol Date
    date
    Does the subject continue to meet all eligibility criteria?
    Item
    Does the subject continue to meet all eligibility criteria?
    boolean
    Item Group
    Study Drug Administration
    Item
    Drug Name
    text
    Code List
    Drug Name
    CL Item
    Brevicon (1)
    Was the dose administered?
    Item
    Was the dose administered?
    boolean
    Dose Date
    Item
    Dose Date
    date
    Dose Time
    Item
    Dose Time
    time
    Dose
    Item
    Dose
    text
    Unit
    Item
    Unit
    text
    Comment
    Item
    Comment
    text
    Item Group
    Pharmacogenetic Blood Collection
    Was the sample collected?
    Item
    Was the sample collected?
    boolean
    Item
    Timepoint
    text
    Code List
    Timepoint
    CL Item
    Pre-dose (1)
    Sample Date
    Item
    Sample Date
    date
    Sample Time
    Item
    Sample Time
    time
    Comment
    Item
    Comment
    text
    Item Group
    Vital Signs
    Date of Vital Signs
    Item
    Date of Vital Signs
    date
    Item
    Duplicate Number
    integer
    Code List
    Duplicate Number
    CL Item
    Duplicate 1 (1)
    CL Item
    Duplicate 2 (2)
    Time
    Item
    Time
    time
    Blood Pressure - Systolic
    Item
    Blood Pressure - Systolic
    float
    Blood Pressure - Diastolic
    Item
    Blood Pressure - Diastolic
    float
    Heart Rate
    Item
    Heart Rate
    integer
    Temperature
    Item
    Temperature
    float
    Body Position
    Item
    Body Position
    text
    Comment
    Item
    Comment
    text
    Item Group
    Pharmacodynamic Blood Collection
    Was the sample collected?
    Item
    Was the sample collected?
    boolean
    Item
    Hormone
    text
    Code List
    Hormone
    CL Item
    LS / FSH (SP Chemistry) (1)
    Item
    Timepoint
    text
    Code List
    Timepoint
    CL Item
    Pre-dose (1)
    Sample Date
    Item
    Sample Date
    date
    Sample Time
    Item
    Sample Time
    time
    Comment
    Item
    Comment
    text

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