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ID

33969

Description

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains information about any unscheduled blood sampling for pharmakokinetics. It should be filled out at each visit, if any unscheduled blood samples for pharmacokinetics had been taken. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Mots-clés

  1. 03/12/2018 03/12/2018 -
  2. 19/12/2018 19/12/2018 -
  3. 09/01/2019 09/01/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

9 janvier 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

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    Effect of Lamictal on Resting Motor Threshold Study-ID 107434

    Unscheduled Blood Sampling for PK

    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Screening number
    Description

    Subject Screening No.

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0220908
    UMLS CUI [1,2]
    C0600091
    Subject no.
    Description

    Subject Number

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Were any unscheduled blood sampling for PK conducted?
    Description

    Unscheduled Blood Sampling

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C3854240
    Staff initials
    Description

    Staff initials

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2986440
    UMLS CUI [1,2]
    C1552089
    Unscheduled Blood Sampling for PK
    Description

    Unscheduled Blood Sampling for PK

    Alias
    UMLS CUI-1
    C0005834
    UMLS CUI-2
    C3854240
    UMLS CUI-3
    C0031327
    Date
    Description

    Date

    Type de données

    date

    Alias
    UMLS CUI [1]
    C0011008
    Actual Time
    Description

    Actual Time

    Type de données

    time

    Alias
    UMLS CUI [1]
    C0040223
    Sample Number
    Description

    Sample Number

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1299222
    PK sample type number
    Description

    PK sample type number

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0201734
    UMLS CUI [1,2]
    C1299222
    Clinical Staff Initials
    Description

    Clinical Staff Initials

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2986440
    UMLS CUI [1,2]
    C0871685
    Reason for Unscheduled Sample
    Description

    Reason for Unscheduled Sample

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0005834
    UMLS CUI [1,3]
    C3854240

    Similar models

    Unscheduled Blood Sampling for PK

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Screening No.
    Item
    Subject Screening number
    integer
    C0220908 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Subject Number
    Item
    Subject no.
    integer
    C2348585 (UMLS CUI [1])
    Unscheduled Blood Sampling
    Item
    Were any unscheduled blood sampling for PK conducted?
    boolean
    C0005834 (UMLS CUI [1,1])
    C3854240 (UMLS CUI [1,2])
    Staff initials
    Item
    Staff initials
    text
    C2986440 (UMLS CUI [1,1])
    C1552089 (UMLS CUI [1,2])
    Item Group
    Unscheduled Blood Sampling for PK
    C0005834 (UMLS CUI-1)
    C3854240 (UMLS CUI-2)
    C0031327 (UMLS CUI-3)
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    Sample Number
    Item
    Sample Number
    text
    C1299222 (UMLS CUI [1])
    Item
    PK sample type number
    integer
    C0201734 (UMLS CUI [1,1])
    C1299222 (UMLS CUI [1,2])
    Code List
    PK sample type number
    CL Item
    1 (1)
    Clinical Staff Initials
    Item
    Clinical Staff Initials
    text
    C2986440 (UMLS CUI [1,1])
    C0871685 (UMLS CUI [1,2])
    Reason for Unscheduled Sample
    Item
    Reason for Unscheduled Sample
    text
    C0392360 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    C3854240 (UMLS CUI [1,3])

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