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25995

Beschreibung

PART A - Period 1 - PK Sampling Day - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Stichworte

Versionen (2)
  1. 2017-10-03 2017-10-03 -
  2. 2017-10-03 2017-10-03 -
Rechteinhaber

glaxoSmithKline

Hochgeladen am

3 oktober 2017

DOI

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Lizenz

Creative Commons BY-NC 3.0
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    PART A - Period 1 - PK Sampling Day - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

    Englisch

    PART A - Period 1 - PK Sampling Day - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

    1 Formulare  
    Orthostatic blood pressure / Pulse - Predose
    Beschreibung

    Orthostatic blood pressure / Pulse - Predose

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C1095971
    UMLS CUI-3
    C0232117
    UMLS CUI-4
    C3812758
    Date of visit
    Beschreibung

    Date of visit

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C1320303
    UMLS CUI [1,2]
    C3812758
    Time
    Beschreibung

    Time vital signs

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0040223
    Heart Rate semi-supine
    Beschreibung

    Heart rate Semi-Supine

    Datentyp

    integer

    Maßeinheiten
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0038846
    UMLS CUI [1,3]
    C3812758
    bpm
    Heart Rate standing
    Beschreibung

    Heart Rate standing

    Datentyp

    integer

    Maßeinheiten
    • bpm
    Alias
    UMLS CUI [1,1]
    C2029905
    UMLS CUI [1,2]
    C3812758
    bpm
    Systolic blood pressure semi-supine
    Beschreibung

    Systolic blood pressure semi-supine

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0038846
    UMLS CUI [1,3]
    C3812758
    mmHg
    Diastolic blood pressure semi-supine
    Beschreibung

    Diastolic blood pressure semi-supine

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0038846
    UMLS CUI [1,3]
    C3812758
    mmHg
    Systolic blood pressure standing
    Beschreibung

    Systolic blood pressure standing

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0231472
    UMLS CUI [1,3]
    C3812758
    mmHg
    Diastolic blood pressure standing
    Beschreibung

    Diastolic blood pressure standing

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1,1]
    C1303019
    UMLS CUI [1,2]
    C3812758
    mmHg
    Concomitant medication
    Beschreibung

    Concomitant medication

    Alias
    UMLS CUI-1
    C2347852
    Has the subject had any changes in medication since the last study visit?
    Beschreibung

    If 'Yes', please document on the Concomitant Medication Report Forms.

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0580105
    Have the subject's smoking habits remained unchanged?
    Beschreibung

    tobacco use unchanged

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0543414
    UMLS CUI [1,2]
    C0442739
    Has the subject been reminded to comply with suggested dietary restrictions?
    Beschreibung

    dietary restrictions

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0425422
    UMLS CUI [1,2]
    C1321605
    Has the subject continued to refrain from alcohol consumption as instructed?
    Beschreibung

    alcohol consumption restricted

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C0443288
    Adverse event
    Beschreibung

    Adverse event

    Alias
    UMLS CUI-1
    C0877248
    Has the subject experienced any Adverse Events since the last study contact?
    Beschreibung

    If 'Yes', please document on the Adverse Event Report Forms.

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0877248
    Patient diary
    Beschreibung

    Patient diary

    Alias
    UMLS CUI-1
    C3890583
    Please collect and review the Patient Diary with the subject. If corrections or additional information are required, please ask the subject to provide missing information or clarification. Please use the Comments CRF pages as necessary. Document any missed doses on the appropriate CRF page. Please inform the subject that he/she should bring back the diary at the next visit.
    Beschreibung

    Patient diary

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C3890583
    Standard Breakfast
    Beschreibung

    Standard Breakfast

    Alias
    UMLS CUI-1
    C2698559
    Breakfast started
    Beschreibung

    Breakfast started

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C2698559
    UMLS CUI [1,2]
    C0439659
    Breakfast ended
    Beschreibung

    Breakfast ended

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C2698559
    UMLS CUI [1,2]
    C0444930
    Did the subject complete the breakfast?
    Beschreibung

    Breakfast completed

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0814440
    UMLS CUI [1,2]
    C0205197
    If no, please comment:
    Beschreibung

    Breakfast not completed comment

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C0814440
    UMLS CUI [1,3]
    C0205197
    Pharmacokinetics
    Beschreibung

    Pharmacokinetics

    Alias
    UMLS CUI-1
    C0031327
    PK specimen drawn
    Beschreibung

    prior to dosing

    Datentyp

    time

    Maßeinheiten
    • hh:mm
    Alias
    UMLS CUI [1,1]
    C0031327
    UMLS CUI [1,2]
    C0807979
    hh:mm
    Study Drug Dosing
    Beschreibung

    Study Drug Dosing

    Alias
    UMLS CUI-1
    C0013175
    UMLS CUI-2
    C0678766
    Dosage given
    Beschreibung

    The subject will not be allowed to lie down or sleep for 4 hours after the morning dose. For subjects receiving IR please document time of administration of 2 further doses on PK Sampling Day.

    Datentyp

    float

    Maßeinheiten
    • mg/day
    Alias
    UMLS CUI [1]
    C0678766
    mg/day
    Dosage
    Beschreibung

    Dosage

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C3854006
    Time of dosing
    Beschreibung

    Time of Dosing

    Datentyp

    time

    Maßeinheiten
    • 24hr:min
    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0040223
    24hr:min
    Was study medication dispensed to the subject?
    Beschreibung

    Study medication dispensed

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C3854006
    UMLS CUI [1,2]
    C0947323
    Witness 1
    Beschreibung

    Witness 1

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0682356
    UMLS CUI [1,2]
    C0001555
    Witness date 1
    Beschreibung

    Witness date 1

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C4263486
    UMLS CUI [1,2]
    C0011008
    Witness 2
    Beschreibung

    Witness 2

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0682356
    UMLS CUI [1,2]
    C0001555
    Witness date 2
    Beschreibung

    Witness date 2

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C4263486
    UMLS CUI [1,2]
    C0011008
    Study Drug Dosing - Lunch
    Beschreibung

    Study Drug Dosing - Lunch

    Alias
    UMLS CUI-1
    C0013175
    UMLS CUI-2
    C0678766
    UMLS CUI-3
    C2697949
    Lunch started
    Beschreibung

    Lunch start

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C2697949
    UMLS CUI [1,2]
    C0439659
    Lunch ended
    Beschreibung

    Lunch end

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C2697949
    UMLS CUI [1,2]
    C0444930
    8 hours after first dose - date
    Beschreibung

    8 hours after first dose - date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0439568
    8 hours after first dose - time
    Beschreibung

    8 hours after first dose - time

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0439568
    Witness 1
    Beschreibung

    Witness 1

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0682356
    UMLS CUI [1,2]
    C0001555
    Witness date 1
    Beschreibung

    Witness date 1

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C4263486
    UMLS CUI [1,2]
    C0011008
    Witness 2
    Beschreibung

    Witness 2

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0682356
    UMLS CUI [1,2]
    C0001555
    Witness date 2
    Beschreibung

    Witness date 2

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C4263486
    UMLS CUI [1,2]
    C0011008
    Study Drug Dosing - Dinner
    Beschreibung

    Study Drug Dosing - Dinner

    Alias
    UMLS CUI-1
    C0013175
    UMLS CUI-2
    C0678766
    UMLS CUI-3
    C4048877
    Dinner started
    Beschreibung

    Dinner start

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C4048877
    UMLS CUI [1,2]
    C0439659
    Dinner ended
    Beschreibung

    Dinner end

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C4048877
    UMLS CUI [1,2]
    C0444930
    16 hours after first dose - date
    Beschreibung

    16 hours after first dose - date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0439568
    16 hours after first dose - time
    Beschreibung

    16 hours after first dose - time

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0439568
    Witness 1
    Beschreibung

    Witness 1

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0682356
    UMLS CUI [1,2]
    C0001555
    Witness date 1
    Beschreibung

    Witness date 1

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C4263486
    UMLS CUI [1,2]
    C0011008
    Witness 2
    Beschreibung

    Witness 2

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0682356
    UMLS CUI [1,2]
    C0001555
    Witness date 2
    Beschreibung

    Witness date 2

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C4263486
    UMLS CUI [1,2]
    C0011008
    Pharmacokinetic sampling post dosing (CR)
    Beschreibung

    Pharmacokinetic sampling post dosing (CR)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0370003
    Sample ID and specified time
    Beschreibung

    Sample ID and specified time

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1299222
    UMLS CUI [1,2]
    C1444698
    Actual time
    Beschreibung

    Actual time sample

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0200345
    UMLS CUI [1,2]
    C0040223
    Date
    Beschreibung

    Date sample

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1302413
    Pharmacokinetic sampling post dosing (IR)
    Beschreibung

    Pharmacokinetic sampling post dosing (IR)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0370003
    Sample ID and specified time
    Beschreibung

    Sample ID and specified time

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1299222
    UMLS CUI [1,2]
    C1444698
    Actual time
    Beschreibung

    Actual time sample

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0200345
    UMLS CUI [1,2]
    C0040223
    Date
    Beschreibung

    Date sample

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1302413
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    Ähnliche Modelle

    PART A - Period 1 - PK Sampling Day - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Orthostatic blood pressure / Pulse - Predose
    C0518766 (UMLS CUI-1)
    C1095971 (UMLS CUI-2)
    C0232117 (UMLS CUI-3)
    C3812758 (UMLS CUI-4)
    Date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1,1])
    C3812758 (UMLS CUI [1,2])
    Time vital signs
    Item
    Time
    time
    C0518766 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Heart rate Semi-Supine
    Item
    Heart Rate semi-supine
    integer
    C0018810 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    C3812758 (UMLS CUI [1,3])
    Heart Rate standing
    Item
    Heart Rate standing
    integer
    C2029905 (UMLS CUI [1,1])
    C3812758 (UMLS CUI [1,2])
    Systolic blood pressure semi-supine
    Item
    Systolic blood pressure semi-supine
    integer
    C0871470 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    C3812758 (UMLS CUI [1,3])
    Diastolic blood pressure semi-supine
    Item
    Diastolic blood pressure semi-supine
    integer
    C0428883 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    C3812758 (UMLS CUI [1,3])
    Systolic blood pressure standing
    Item
    Systolic blood pressure standing
    integer
    C0871470 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    C3812758 (UMLS CUI [1,3])
    Diastolic blood pressure standing
    Item
    Diastolic blood pressure standing
    integer
    C1303019 (UMLS CUI [1,1])
    C3812758 (UMLS CUI [1,2])
    Item Group
    Concomitant medication
    C2347852 (UMLS CUI-1)
    Item
    Has the subject had any changes in medication since the last study visit?
    integer
    C0580105 (UMLS CUI [1])
    changes in medication
    Code List
    Has the subject had any changes in medication since the last study visit?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item
    Have the subject's smoking habits remained unchanged?
    integer
    C0543414 (UMLS CUI [1,1])
    C0442739 (UMLS CUI [1,2])
    tobacco use unchanged
    Code List
    Have the subject's smoking habits remained unchanged?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item
    Has the subject been reminded to comply with suggested dietary restrictions?
    integer
    C0425422 (UMLS CUI [1,1])
    C1321605 (UMLS CUI [1,2])
    dietary restrictions
    Code List
    Has the subject been reminded to comply with suggested dietary restrictions?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item
    Has the subject continued to refrain from alcohol consumption as instructed?
    integer
    C0001948 (UMLS CUI [1,1])
    C0443288 (UMLS CUI [1,2])
    alcohol consumption restricted
    Code List
    Has the subject continued to refrain from alcohol consumption as instructed?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item Group
    Adverse event
    C0877248 (UMLS CUI-1)
    Item
    Has the subject experienced any Adverse Events since the last study contact?
    integer
    C0877248 (UMLS CUI [1])
    adverse event
    Code List
    Has the subject experienced any Adverse Events since the last study contact?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item Group
    Patient diary
    C3890583 (UMLS CUI-1)
    Patient diary
    Item
    Please collect and review the Patient Diary with the subject. If corrections or additional information are required, please ask the subject to provide missing information or clarification. Please use the Comments CRF pages as necessary. Document any missed doses on the appropriate CRF page. Please inform the subject that he/she should bring back the diary at the next visit.
    text
    C3890583 (UMLS CUI [1])
    Item Group
    Standard Breakfast
    C2698559 (UMLS CUI-1)
    Breakfast started
    Item
    Breakfast started
    time
    C2698559 (UMLS CUI [1,1])
    C0439659 (UMLS CUI [1,2])
    Breakfast ended
    Item
    Breakfast ended
    time
    C2698559 (UMLS CUI [1,1])
    C0444930 (UMLS CUI [1,2])
    Breakfast completed
    Item
    Did the subject complete the breakfast?
    boolean
    C0814440 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    Breakfast not completed comment
    Item
    If no, please comment:
    text
    C0947611 (UMLS CUI [1,1])
    C0814440 (UMLS CUI [1,2])
    C0205197 (UMLS CUI [1,3])
    Item Group
    Pharmacokinetics
    C0031327 (UMLS CUI-1)
    Pharmacokinetics
    Item
    PK specimen drawn
    time
    C0031327 (UMLS CUI [1,1])
    C0807979 (UMLS CUI [1,2])
    Item Group
    Study Drug Dosing
    C0013175 (UMLS CUI-1)
    C0678766 (UMLS CUI-2)
    Dosage given
    Item
    Dosage given
    float
    C0678766 (UMLS CUI [1])
    Item
    Dosage
    integer
    C0178602 (UMLS CUI [1,1])
    C3854006 (UMLS CUI [1,2])
    Dosage
    Code List
    Dosage
    CL Item
    CR (1)
    CL Item
    IR (2)
    Time of Dosing
    Item
    Time of dosing
    time
    C0178602 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Was study medication dispensed to the subject?
    integer
    C3854006 (UMLS CUI [1,1])
    C0947323 (UMLS CUI [1,2])
    Study medication dispensed
    Code List
    Was study medication dispensed to the subject?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    NA (3)
    Witness 1
    Item
    Witness 1
    text
    C0682356 (UMLS CUI [1,1])
    C0001555 (UMLS CUI [1,2])
    Witness date 1
    Item
    Witness date 1
    date
    C4263486 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Witness 2
    Item
    Witness 2
    text
    C0682356 (UMLS CUI [1,1])
    C0001555 (UMLS CUI [1,2])
    Witness date 2
    Item
    Witness date 2
    date
    C4263486 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Study Drug Dosing - Lunch
    C0013175 (UMLS CUI-1)
    C0678766 (UMLS CUI-2)
    C2697949 (UMLS CUI-3)
    Lunch start
    Item
    Lunch started
    time
    C2697949 (UMLS CUI [1,1])
    C0439659 (UMLS CUI [1,2])
    Lunch end
    Item
    Lunch ended
    time
    C2697949 (UMLS CUI [1,1])
    C0444930 (UMLS CUI [1,2])
    8 hours after first dose - date
    Item
    8 hours after first dose - date
    date
    C0011008 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    8 hours after first dose - time
    Item
    8 hours after first dose - time
    time
    C0040223 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    Witness 1
    Item
    Witness 1
    text
    C0682356 (UMLS CUI [1,1])
    C0001555 (UMLS CUI [1,2])
    Witness date 1
    Item
    Witness date 1
    date
    C4263486 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Witness 2
    Item
    Witness 2
    text
    C0682356 (UMLS CUI [1,1])
    C0001555 (UMLS CUI [1,2])
    Witness date 2
    Item
    Witness date 2
    date
    C4263486 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Study Drug Dosing - Dinner
    C0013175 (UMLS CUI-1)
    C0678766 (UMLS CUI-2)
    C4048877 (UMLS CUI-3)
    Dinner start
    Item
    Dinner started
    time
    C4048877 (UMLS CUI [1,1])
    C0439659 (UMLS CUI [1,2])
    Dinner end
    Item
    Dinner ended
    time
    C4048877 (UMLS CUI [1,1])
    C0444930 (UMLS CUI [1,2])
    16 hours after first dose - date
    Item
    16 hours after first dose - date
    date
    C0011008 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    16 hours after first dose - time
    Item
    16 hours after first dose - time
    time
    C0040223 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    Witness 1
    Item
    Witness 1
    text
    C0682356 (UMLS CUI [1,1])
    C0001555 (UMLS CUI [1,2])
    Witness date 1
    Item
    Witness date 1
    date
    C4263486 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Witness 2
    Item
    Witness 2
    text
    C0682356 (UMLS CUI [1,1])
    C0001555 (UMLS CUI [1,2])
    Witness date 2
    Item
    Witness date 2
    date
    C4263486 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Pharmacokinetic sampling post dosing (CR)
    C0031328 (UMLS CUI-1)
    C0370003 (UMLS CUI-2)
    Item
    Sample ID and specified time
    integer
    C1299222 (UMLS CUI [1,1])
    C1444698 (UMLS CUI [1,2])
    Sample ID and specified time
    Code List
    Sample ID and specified time
    CL Item
    1h (1)
    CL Item
    2h (2)
    CL Item
    4h (3)
    CL Item
    6h (4)
    CL Item
    8h (5)
    CL Item
    10h (6)
    CL Item
    12h (7)
    CL Item
    14h (8)
    CL Item
    16h (9)
    CL Item
    20h (10)
    CL Item
    24h (11)
    Actual time sample
    Item
    Actual time
    time
    C0200345 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Date sample
    Item
    Date
    date
    C1302413 (UMLS CUI [1])
    Item Group
    Pharmacokinetic sampling post dosing (IR)
    C0031328 (UMLS CUI-1)
    C0370003 (UMLS CUI-2)
    Item
    Sample ID and specified time
    integer
    C1299222 (UMLS CUI [1,1])
    C1444698 (UMLS CUI [1,2])
    Sample ID and specified time
    Code List
    Sample ID and specified time
    CL Item
    0.25h (1)
    CL Item
    0.5h (2)
    CL Item
    1.0h (3)
    CL Item
    1.5h (4)
    CL Item
    2h (5)
    CL Item
    3h (6)
    CL Item
    4h (7)
    CL Item
    6h (8)
    CL Item
    8h (9)
    CL Item
    8.25h (10)
    CL Item
    8.5h (11)
    CL Item
    9h (12)
    CL Item
    9.5h (13)
    CL Item
    10h (14)
    CL Item
    11h (15)
    CL Item
    12h (16)
    CL Item
    14h (17)
    CL Item
    16h (18)
    CL Item
    16.25h (19)
    CL Item
    16.5h (20)
    CL Item
    17h (21)
    CL Item
    17.5h (22)
    CL Item
    18h (23)
    CL Item
    19h (24)
    CL Item
    20h (25)
    CL Item
    22h (26)
    CL Item
    24h (27)
    Actual time sample
    Item
    Actual time
    time
    C0200345 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Date sample
    Item
    Date
    date
    C1302413 (UMLS CUI [1])
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