ID

33731

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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

Nyckelord

  1. 2018-12-21 2018-12-21 -
Rättsinnehavare

GSK group of companies

Uppladdad den

21 december 2018

DOI

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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 1 (Visit 80)

    Administrative data
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    Administrative data

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    Site

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    Subject
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    Subject

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    blank page?

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    boolean

    Visit Date
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    date

    Admission Criteria
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    Admission Criteria

    Protocol Date
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    Protocol Date

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    date

    Does the subject continue to meet all eligibility criteria?
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    Does the subject continue to meet all eligibility criteria?

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    boolean

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    Study Drug Administration

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    boolean

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    Dose Date

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    date

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    Dose Time

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    time

    Dose
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    e.g., 0.5/0.035

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    e.g., mg

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    Comment
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    Laboratory Test - Hematology
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    Laboratory Test - Hematology

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    Laboratory Test - Chemistry

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    Laboratory Test - UA / UDS / Urine HCG / Urine Chemistry
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    Laboratory Test - UA / UDS / Urine HCG / Urine Chemistry

    Was the laboratory sample collected?
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    Was the laboratory sample collected?

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    boolean

    Sample Date
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    Heart Rate
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    e.g., Sitting

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    text

    Comment
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    Comment

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    Pharmacodynamic Blood Collection

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    Pharmacodynamic Blood Collection
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    Pharmacodynamic Blood Collection

    Was the sample collected?
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    Was the sample collected?

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    boolean

    Hormone
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    Hormone

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    Timepoint
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    Sample Date
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    time

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    Sample Time

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    Comment

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    Similar models

    Period 1 Day 1 (Visit 80)

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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 1 (1)
    Status
    Item
    Status
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    Doc №
    Item
    Doc №
    integer
    blank page?
    Item
    Is Page Blank?
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    Visit Date
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    Protocol Date
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    Does the subject continue to meet all eligibility criteria?
    Item
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    Item Group
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    Item
    Drug Name
    text
    Code List
    Drug Name
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    Was the dose administered?
    Item
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    boolean
    Dose Date
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    Dose Date
    date
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    Dose Time
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    Dose
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    Dose
    text
    Unit
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    Unit
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    Comment
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    Laboratory Test - Hematology
    Was laboratory sample collected?
    Item
    Was laboratory sample collected?
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    Sample Date
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    Sample Date
    date
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    Laboratory Test - Chemistry
    Was the laboratory sample collected?
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    Sample Date
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    date
    Sample Time
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    Item Group
    Laboratory Test - UA / UDS / Urine HCG / Urine Chemistry
    Was the laboratory sample collected?
    Item
    Was the laboratory sample collected?
    boolean
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    Item Group
    Vital Signs
    Date of Vital Signs
    Item
    Date of Vital Signs
    date
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    Duplicate Number
    integer
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    CL Item
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    CL Item
    Duplicate 2 (2)
    Time
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    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
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    float
    Body Position
    Item
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    text
    Comment
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    Comment
    text
    Item Group
    Pharmacodynamic Blood Collection
    Was the sample collected?
    Item
    Was the sample collected?
    boolean
    Item
    Hormone
    text
    Code List
    Hormone
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    Progesterone (SP Chem) (1)
    Item
    Timepoint
    text
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    Timepoint
    CL Item
    Pre-dose (1)
    Sample Date
    Item
    Sample Date
    date
    Sample Time
    Item
    Sample Time
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    Comment
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    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
    LH / FSH (SP Chemistry) (1)
    Item
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    text
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    CL Item
    Pre-dose (1)
    Sample Date
    Item
    Sample Date
    time
    Sample Time
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    Sample Time
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    Comment
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    Comment
    text

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