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ID

41692

Description

The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out at the P1 D1 and P2 D1 Visit.

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Versions (2)
  1. 12/17/20 12/17/20 -
  2. 12/18/20 12/18/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 18, 2020

DOI

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License

Creative Commons BY-NC 4.0
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    GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122

    English

    Pharmacokinetics

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

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    date of visit
    Description

    date of visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    subject ID
    Description

    subject ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    visit type
    Description

    visit type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Dosing date and time
    Description

    Dosing date and time

    Alias
    UMLS CUI-1
    C0013227
    UMLS CUI-2
    C0178602
    UMLS CUI-3
    C0011008
    UMLS CUI-4
    C0040223
    dosing date and time
    Description

    dosing date and time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [2,1]
    C0013227
    UMLS CUI [2,2]
    C0178602
    UMLS CUI [2,3]
    C0040223
    Pharmacokinetics Blood
    Description

    Pharmacokinetics Blood

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    time relative to dosage
    Description

    time relative to dosage

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C0178602
    actual time
    Description

    this item has to be filled out for each measurement.

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0040223
    actual date
    Description

    this item only has to be filled out starting at 24hours past dosage and for each measurement after that.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0011008
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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
    Administrative Data
    C1320722 (UMLS CUI-1)
    date of visit
    Item
    date of visit
    date
    C1320303 (UMLS CUI [1])
    subject ID
    Item
    subject ID
    text
    C2348585 (UMLS CUI [1])
    Item
    visit type
    text
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    visit type
    Code List
    visit type
    CL Item
    P1 D1 (1)
    CL Item
    P2 D1 (2)
    Item Group
    Dosing date and time
    C0013227 (UMLS CUI-1)
    C0178602 (UMLS CUI-2)
    C0011008 (UMLS CUI-3)
    C0040223 (UMLS CUI-4)
    dosing date and time
    Item
    dosing date and time
    datetime
    C0013227 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0013227 (UMLS CUI [2,1])
    C0178602 (UMLS CUI [2,2])
    C0040223 (UMLS CUI [2,3])
    Item Group
    Pharmacokinetics Blood
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    Item
    time relative to dosage
    text
    C0439564 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    time relative to dosage
    Code List
    time relative to dosage
    CL Item
    pre-dose (1)
    CL Item
    0.5hr (2)
    CL Item
    1hr (3)
    CL Item
    1.5hr (4)
    CL Item
    2hr (5)
    CL Item
    3hr (6)
    CL Item
    4hr (7)
    CL Item
    6hr (8)
    CL Item
    8hr (9)
    CL Item
    12hr (10)
    CL Item
    16hr (11)
    CL Item
    24hr (12)
    CL Item
    48hr (13)
    CL Item
    72hr (14)
    pharmacokinetics: actual time
    Item
    actual time
    time
    C0031328 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    pharmacokinetics: actual date
    Item
    actual date
    date
    C0031328 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
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