0 Bedömningar

ID

33778

Beskrivning

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. 2018-12-27 2018-12-27 -
  2. 2018-12-27 2018-12-27 -
Rättsinnehavare

GSK group of companies

Uppladdad den

27 december 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :


    Inga kommentarer

    Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

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

    Period 2 Day 11 + Day 12

    Administrative data
    Beskrivning

    Administrative data

    Study Site
    Beskrivning

    Site

    Datatyp

    text

    Subject
    Beskrivning

    Subject

    Datatyp

    text

    Visit Name
    Beskrivning

    Visit Name

    Datatyp

    text

    Visit Number
    Beskrivning

    Visit Number

    Datatyp

    text

    Status
    Beskrivning

    Status

    Datatyp

    text

    Document Number
    Beskrivning

    Document Number

    Datatyp

    integer

    Day 11
    Beskrivning

    Day 11

    Visit Date
    Beskrivning

    Visit Date

    Datatyp

    date

    Vital Signs - Duplicate 1
    Beskrivning

    Vital Signs - Duplicate 1

    Time of Vital Signs
    Beskrivning

    Time of Vital Signs

    Datatyp

    time

    Blood Pressure - Systolic
    Beskrivning

    Blood Pressure - Systolic

    Datatyp

    float

    Måttenheter
    • mmHg
    mmHg
    Blood Pressure - Diastolic
    Beskrivning

    Blood Pressure - Diastolic

    Datatyp

    float

    Måttenheter
    • mmHg
    mmHg
    Heart Rate
    Beskrivning

    Heart Rate

    Datatyp

    integer

    Måttenheter
    • bpm
    bpm
    Temperature
    Beskrivning

    Temperature

    Datatyp

    float

    Måttenheter
    • °C
    °C
    Body Position
    Beskrivning

    e.g., Sitting

    Datatyp

    text

    Comment
    Beskrivning

    Comment

    Datatyp

    text

    Vital Signs - Duplicate 2
    Beskrivning

    Vital Signs - Duplicate 2

    Time of Vital Signs
    Beskrivning

    Time of Vital Signs

    Datatyp

    time

    Blood Pressure - Systolic
    Beskrivning

    Blood Pressure - Systolic

    Datatyp

    float

    Måttenheter
    • mmHg
    mmHg
    Blood Pressure - Diastolic
    Beskrivning

    Blood Pressure - Diastolic

    Datatyp

    float

    Måttenheter
    • mmHg
    mmHg
    Heart Rate
    Beskrivning

    Heart Rate

    Datatyp

    integer

    Måttenheter
    • bpm
    bpm
    Body Position
    Beskrivning

    e.g., Sitting

    Datatyp

    text

    Comment
    Beskrivning

    Comment

    Datatyp

    text

    Study Drug Administration
    Beskrivning

    Study Drug Administration

    Drug Name
    Beskrivning

    Drug Name

    Datatyp

    text

    Was the dose administered?
    Beskrivning

    dose administered?

    Datatyp

    boolean

    Dose Date
    Beskrivning

    Dose Date

    Datatyp

    date

    Dose Time
    Beskrivning

    Dose Time

    Datatyp

    time

    Dose
    Beskrivning

    e.g., 0.5 / 0.035

    Datatyp

    text

    Unit
    Beskrivning

    e.g., mg

    Datatyp

    text

    Comment
    Beskrivning

    Comment

    Datatyp

    text

    Pharmacodynamic Blood Collection
    Beskrivning

    Pharmacodynamic Blood Collection

    Hormone
    Beskrivning

    Hormone

    Datatyp

    text

    Was the sample collected? / Was the test done?
    Beskrivning

    not done/not collected?

    Datatyp

    boolean

    Timepoint
    Beskrivning

    Timepoint

    Datatyp

    text

    Sample Date
    Beskrivning

    Sample Date

    Datatyp

    date

    Sample Time
    Beskrivning

    Sample Time

    Datatyp

    time

    Comment
    Beskrivning

    Comment

    Datatyp

    text

    Day 12
    Beskrivning

    Day 12

    Visit Date
    Beskrivning

    Visit Date

    Datatyp

    date

    Vital Signs - Duplicate 1
    Beskrivning

    Vital Signs - Duplicate 1

    Time of Vital Signs
    Beskrivning

    Time of Vital Signs

    Datatyp

    time

    Blood Pressure - Systolic
    Beskrivning

    Blood Pressure - Systolic

    Datatyp

    float

    Måttenheter
    • mmHg
    mmHg
    Blood Pressure - Diastolic
    Beskrivning

    Blood Pressure - Diastolic

    Datatyp

    float

    Måttenheter
    • mmHg
    mmHg
    Heart Rate
    Beskrivning

    Heart Rate

    Datatyp

    integer

    Måttenheter
    • bpm
    bpm
    Temperature
    Beskrivning

    Temperature

    Datatyp

    float

    Måttenheter
    • °C
    °C
    Body Position
    Beskrivning

    e.g., Sitting

    Datatyp

    float

    Måttenheter
    • °C
    °C
    Comment
    Beskrivning

    Comment

    Datatyp

    text

    Vital Signs - Duplicate 2
    Beskrivning

    Vital Signs - Duplicate 2

    Time of Vital SIgns
    Beskrivning

    Time of Vital SIgns

    Datatyp

    time

    Blood Pressure - Systolic
    Beskrivning

    Blood Pressure - Systolic

    Datatyp

    float

    Måttenheter
    • mmHg
    mmHg
    Blood Pressure - Diastolic
    Beskrivning

    Blood Pressure - Diastolic

    Datatyp

    float

    Måttenheter
    • mmHg
    mmHg
    Heart Rate
    Beskrivning

    Heart Rate

    Datatyp

    integer

    Måttenheter
    • bpm
    bpm
    Body Position
    Beskrivning

    e.g., Sitting

    Datatyp

    text

    Comment
    Beskrivning

    Comment

    Datatyp

    text

    Study Drug Administration
    Beskrivning

    Study Drug Administration

    Drug Name
    Beskrivning

    Drug Name

    Datatyp

    text

    Was the dose administered?
    Beskrivning

    dose administered?

    Datatyp

    boolean

    Dose Date
    Beskrivning

    Dose Date

    Datatyp

    date

    Dose Time
    Beskrivning

    Dose Time

    Datatyp

    time

    Dose
    Beskrivning

    e.g., 0.5 / 0.035

    Datatyp

    text

    Unit
    Beskrivning

    e.g., mg

    Datatyp

    text

    Comment
    Beskrivning

    Comment

    Datatyp

    text

    Study Drug Administration 2
    Beskrivning

    Study Drug Administration 2

    Drug Name
    Beskrivning

    Drug Name

    Datatyp

    text

    Was the dose administered?
    Beskrivning

    dose administered?

    Datatyp

    boolean

    Dose Date
    Beskrivning

    Dose Date

    Datatyp

    date

    Dose Time
    Beskrivning

    Dose Time

    Datatyp

    time

    Dose
    Beskrivning

    e.g., 50

    Datatyp

    text

    Unit
    Beskrivning

    e.g., mg

    Datatyp

    text

    Site of Injection
    Beskrivning

    Site of Injection

    Datatyp

    text

    Comment
    Beskrivning

    Comment

    Datatyp

    text

    Pharmacodynamic Blood Collection
    Beskrivning

    Pharmacodynamic Blood Collection

    Hormone
    Beskrivning

    Hormone

    Datatyp

    text

    Was the sample collected? / Was the test done?
    Beskrivning

    not done/not collected?

    Datatyp

    boolean

    Timepoint
    Beskrivning

    Timepoint

    Datatyp

    text

    Sample Date
    Beskrivning

    Sample Date

    Datatyp

    date

    Sample Time
    Beskrivning

    Sample Time

    Datatyp

    time

    Comment
    Beskrivning

    Comment

    Datatyp

    text

    Similar models

    Period 2 Day 11 + Day 12

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative data
    Site
    Item
    Study Site
    text
    Subject
    Item
    Subject
    text
    Item
    Visit Name
    text
    Code List
    Visit Name
    CL Item
    Period 2 Day 11+ Day 12 (1)
    Item
    Visit Number
    text
    Code List
    Visit Number
    CL Item
    Visit 200 (1)
    Status
    Item
    Status
    text
    Document Number
    Item
    Document Number
    integer
    Item Group
    Day 11
    Visit Date
    Item
    Visit Date
    date
    Item Group
    Vital Signs - Duplicate 1
    Time of Vital Signs
    Item
    Time of Vital Signs
    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
    Vital Signs - Duplicate 2
    Time of Vital Signs
    Item
    Time of Vital Signs
    time
    Blood Pressure - Systolic
    Item
    Blood Pressure - Systolic
    float
    Blood Pressure - Diastolic
    Item
    Blood Pressure - Diastolic
    float
    Heart Rate
    Item
    Heart Rate
    integer
    Body Position
    Item
    Body Position
    text
    Comment
    Item
    Comment
    text
    Item Group
    Study Drug Administration
    Item
    Drug Name
    text
    Code List
    Drug Name
    CL Item
    Brevicon (1)
    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
    Pharmacodynamic Blood Collection
    Item
    Hormone
    text
    Code List
    Hormone
    CL Item
    LH / FSH (SP Chem) (1)
    not done/not collected?
    Item
    Was the sample collected? / Was the test done?
    boolean
    Item
    Timepoint
    text
    Code List
    Timepoint
    CL Item
    Predose (1)
    Sample Date
    Item
    Sample Date
    date
    Sample Time
    Item
    Sample Time
    time
    Comment
    Item
    Comment
    text
    Item Group
    Day 12
    Visit Date
    Item
    Visit Date
    date
    Item Group
    Vital Signs - Duplicate 1
    Time of Vital Signs
    Item
    Time of Vital Signs
    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
    float
    Comment
    Item
    Comment
    text
    Item Group
    Vital Signs - Duplicate 2
    Time of Vital SIgns
    Item
    Time of Vital SIgns
    time
    Blood Pressure - Systolic
    Item
    Blood Pressure - Systolic
    float
    Blood Pressure - Diastolic
    Item
    Blood Pressure - Diastolic
    float
    Heart Rate
    Item
    Heart Rate
    integer
    Body Position
    Item
    Body Position
    text
    Comment
    Item
    Comment
    text
    Item Group
    Study Drug Administration
    Item
    Drug Name
    text
    Code List
    Drug Name
    CL Item
    Brevicon (1)
    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
    Study Drug Administration 2
    Item
    Drug Name
    text
    Code List
    Drug Name
    CL Item
    Albiglutide (1)
    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
    Item
    Site of Injection
    text
    Code List
    Site of Injection
    CL Item
    Right Abdomen (1)
    CL Item
    Left Abdomen (2)
    Comment
    Item
    Comment
    text
    Item Group
    Pharmacodynamic Blood Collection
    Item
    Hormone
    text
    Code List
    Hormone
    CL Item
    LH / FSH (SP Chem) (1)
    not done/not collected?
    Item
    Was the sample collected? / Was the test done?
    boolean
    Item
    Timepoint
    text
    Code List
    Timepoint
    CL Item
    Predose (1)
    Sample Date
    Item
    Sample Date
    date
    Sample Time
    Item
    Sample Time
    time
    Comment
    Item
    Comment
    text

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial