0 Ratings
ID

39098

Description

Study ID: 103106 Clinical Study ID: WXL103106 Study Title:An open-label, 2-period, sequential treatment, 1-way drug interaction study to evaluate the effect of ritonavir on bupropion pharmacokinetics in healthy volunteers 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: bupropion Trade Name: Wellbutrin,QUOMEM,Elontril,Zyban,ZYNTABAC; Zyban,ZYNTABAC,Wellbutrin,Wellburin,QUOMEM,Prolev,Magerion,Geronplase,Elontril Study Indication: Depressive Disorder

Keywords

Versions (1)
  1. 12/1/19 12/1/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 1, 2019

DOI

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License

Creative Commons BY-NC 3.0
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    Effect of Ritonavir on Bupropion Pharmacokinetics; 103106

    English

    Baseline Day -1

    1 forms  
    1. StudyEvent: ODM
      1. Baseline Day -1
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Physical Examination
    Description

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809
    Has a physical examination been performed on the subject?
    Description

    Physical Examination

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0031809
    Was the physical examination?
    Description

    Physical Examination, Test Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0456984
    If Abnormal record below
    Description

    Physical Examination, Abnormal result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0459424
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Date
    Description

    Vital Signs Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826644
    Planned Relative Time
    Description

    Vital signs, Relative time, Planned

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0439564
    UMLS CUI [1,3]
    C1301732
    Actual Time
    Description

    Vital Signs Time

    Data type

    time

    Alias
    UMLS CUI [1]
    C2826762
    Blood Pressure - Semi-supine - Systolic
    Description

    Systolic Pressure, Semi-erect

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0522019
    mm[Hg]
    Blood Pressure - Semi-supine - Diastolic
    Description

    Diastolic blood pressure, Semi-erect

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0522019
    mm[Hg]
    Heart Rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Local Laboratory Result Data (Haematology)
    Description

    Local Laboratory Result Data (Haematology)

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0474523
    Date and time sample taken
    Description

    Laboratory Procedures, Hematology finding, Sampling, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0011008
    UMLS CUI [1,5]
    C0040223
    Has the subject fasted?
    Description

    Laboratory Procedures, Hematology finding, Fasting

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C0015663
    Laboratory Test - Haematology
    Description

    Laboratory Procedures, Hematology finding

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    Result
    Description

    Laboratory Procedures, Hematology finding, Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C1274040
    Local Laboratory Result Data (Clinical Chemistry)
    Description

    Local Laboratory Result Data (Clinical Chemistry)

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0008000
    Date and time sample taken
    Description

    Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0011008
    UMLS CUI [1,5]
    C0040223
    Has the subject fasted?
    Description

    Laboratory Procedures, Clinical, Chemistry, Fasting

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C0015663
    Laboratory Test - Haematology
    Description

    Laboratory Procedures, Chemistry, Clinical

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0008000
    Result
    Description

    Laboratory Procedures, Chemistry, Clinical, Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C1274040
    Urinalysis
    Description

    Urinalysis

    Alias
    UMLS CUI-1
    C0042014
    Date and time sample taken
    Description

    Urinalysis, Sampling, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Result of dipstick
    Description

    Urinalysis, Urine dipstick test, Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0430370
    UMLS CUI [1,3]
    C1274040
    Urinalysis (Dipstick) Test
    Description

    Urinalysis, Urine dipstick test

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0430370
    Result
    Description

    Urinalysis, Urine dipstick test, Test Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0430370
    UMLS CUI [1,3]
    C0456984
    Was sedimentary microscopy performed?
    Description

    Urinalysis, Microscopic urinalysis, Urine Sediment Analysis Measurement

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0430397
    UMLS CUI [1,3]
    C2700128
    Urinalysis (Microscopy) Test
    Description

    Urinalysis, Microscopic urinalysis, Urine Sediment Analysis Measurement

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0430397
    UMLS CUI [1,3]
    C2700128
    Result
    Description

    Urinalysis, Microscopic urinalysis, Urine Sediment Analysis Measurement, Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0430397
    UMLS CUI [1,3]
    C2700128
    UMLS CUI [1,4]
    C1274040
    Drug and Alcohol Screen
    Description

    Drug and Alcohol Screen

    Alias
    UMLS CUI-1
    C0202274
    UMLS CUI-2
    C0202304
    Date and time of sample taken
    Description

    Urine drug screening, Ethanol measurement, Sampling, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0202274
    UMLS CUI [1,2]
    C0202304
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0011008
    UMLS CUI [1,5]
    C0040223
    Cocaine
    Description

    Urine drug screening, Cocaine

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0202274
    UMLS CUI [1,2]
    C0009170
    Amphetamines
    Description

    Urine drug screening, Amphetamines

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0202274
    UMLS CUI [1,2]
    C0002667
    Benzodiazepines
    Description

    Urine drug screening, Benzodiazepines

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0202274
    UMLS CUI [1,2]
    C0005064
    Cannabis
    Description

    Urine drug screening, Cannabis

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0202274
    UMLS CUI [1,2]
    C0936079
    Opiates
    Description

    Urine drug screening, Opiates

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0202274
    UMLS CUI [1,2]
    C0376196
    Barbiturates
    Description

    Urine drug screening, Barbiturates

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0202274
    UMLS CUI [1,2]
    C0004745
    Methadone
    Description

    Urine drug screening, Methadone

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0202274
    UMLS CUI [1,2]
    C0025605
    Alcohol
    Description

    Ethanol measurement

    Data type

    text

    Alias
    UMLS CUI [1]
    C0202304
    Serum Pregnancy Test (Complete for Female Subjects Only)
    Description

    Serum Pregnancy Test (Complete for Female Subjects Only)

    Alias
    UMLS CUI-1
    C0430060
    Date sample taken
    Description

    Serum pregnancy test (B-HCG), Sampling, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0430060
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    Results
    Description

    Serum pregnancy test (B-HCG), Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0430060
    UMLS CUI [1,2]
    C1274040
    Randomisation Number
    Description

    Randomisation Number

    Alias
    UMLS CUI-1
    C0034656
    UMLS CUI-2
    C0237753
    Record randomisation number.
    Description

    Randomization, Numbers

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0237753
    Date of randomisation
    Description

    Randomization, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0011008
    Regimen
    Description

    Regimen

    Alias
    UMLS CUI-1
    C1276413
    Regimen
    Description

    Therapeutic regimen

    Data type

    text

    Alias
    UMLS CUI [1]
    C1276413
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    Similar models

    Baseline Day -1

    1 forms
    1. StudyEvent: ODM
      1. Baseline Day -1
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Physical Examination
    C0031809 (UMLS CUI-1)
    Physical Examination
    Item
    Has a physical examination been performed on the subject?
    boolean
    C0031809 (UMLS CUI [1])
    Item
    Was the physical examination?
    text
    C0031809 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    Physical Examination, Test Result
    Code List
    Was the physical examination?
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    Physical Examination, Abnormal result
    Item
    If Abnormal record below
    text
    C0031809 (UMLS CUI [1,1])
    C0459424 (UMLS CUI [1,2])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Vital Signs Date
    Item
    Date
    date
    C2826644 (UMLS CUI [1])
    Item
    Planned Relative Time
    text
    C0518766 (UMLS CUI [1,1])
    C0439564 (UMLS CUI [1,2])
    C1301732 (UMLS CUI [1,3])
    Vital signs, Relative time, Planned
    Code List
    Planned Relative Time
    CL Item
    Screening (1)
    Vital Signs Time
    Item
    Actual Time
    time
    C2826762 (UMLS CUI [1])
    Systolic Pressure, Semi-erect
    Item
    Blood Pressure - Semi-supine - Systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0522019 (UMLS CUI [1,2])
    Diastolic blood pressure, Semi-erect
    Item
    Blood Pressure - Semi-supine - Diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0522019 (UMLS CUI [1,2])
    Heart rate
    Item
    Heart Rate
    integer
    C0018810 (UMLS CUI [1])
    Item Group
    Local Laboratory Result Data (Haematology)
    C0022885 (UMLS CUI-1)
    C0474523 (UMLS CUI-2)
    Laboratory Procedures, Hematology finding, Sampling, Date in time, Time
    Item
    Date and time sample taken
    datetime
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    C0040223 (UMLS CUI [1,5])
    Laboratory Procedures, Hematology finding, Fasting
    Item
    Has the subject fasted?
    boolean
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C0015663 (UMLS CUI [1,3])
    Item
    Laboratory Test - Haematology
    text
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    Laboratory Procedures, Hematology finding
    Code List
    Laboratory Test - Haematology
    CL Item
    Hemoglobin (1)
    CL Item
    Hematocrit (2)
    CL Item
    RBC count (3)
    CL Item
    WBC count (4)
    CL Item
    Platelet count (5)
    CL Item
    Neutrophils (6)
    CL Item
    Lymphocytes (7)
    CL Item
    Monocytes (8)
    CL Item
    Basophils (9)
    CL Item
    Eosinophils (10)
    Laboratory Procedures, Hematology finding, Result
    Item
    Result
    text
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Item Group
    Local Laboratory Result Data (Clinical Chemistry)
    C0022885 (UMLS CUI-1)
    C0008000 (UMLS CUI-2)
    Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time, Time
    Item
    Date and time sample taken
    datetime
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    C0040223 (UMLS CUI [1,5])
    Laboratory Procedures, Clinical, Chemistry, Fasting
    Item
    Has the subject fasted?
    boolean
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0015663 (UMLS CUI [1,3])
    Item
    Laboratory Test - Haematology
    text
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    Laboratory Procedures, Hematology finding
    Code List
    Laboratory Test - Haematology
    CL Item
    Sodium (1)
    CL Item
    Potassium (2)
    CL Item
    Bicarbonate (3)
    CL Item
    Glucose (4)
    CL Item
    Albumin (5)
    CL Item
    Total protein (6)
    CL Item
    Creatinine (7)
    CL Item
    Total bilirubin (8)
    CL Item
    Alanine aminotransferase (ALT) (9)
    CL Item
    Aspartate aminotransferase (AST) (10)
    CL Item
    Alkaline phosphatase (ALP) (11)
    CL Item
    Lactate dehydrogenase (LDH) (12)
    CL Item
    Urea (BUN) (13)
    CL Item
    Cholesterol (14)
    CL Item
    HDL (15)
    CL Item
    LDL (16)
    CL Item
    Triglyceride (17)
    Laboratory Procedures, Chemistry, Clinical, Result
    Item
    Result
    text
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Item Group
    Urinalysis
    C0042014 (UMLS CUI-1)
    Urinalysis, Sampling, Date in time, Time
    Item
    Date and time sample taken
    datetime
    C0042014 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Item
    Result of dipstick
    text
    C0042014 (UMLS CUI [1,1])
    C0430370 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Urinalysis, Dipstick, Result
    Code List
    Result of dipstick
    CL Item
    Negative (1)
    CL Item
    Positive (2)
    CL Item
    No result (3)
    Item
    Urinalysis (Dipstick) Test
    text
    C0042014 (UMLS CUI [1,1])
    C0430370 (UMLS CUI [1,2])
    Urinalysis, Urine dipstick test
    Code List
    Urinalysis (Dipstick) Test
    CL Item
    Specific gravity (1)
    CL Item
    pH (2)
    CL Item
    Protein (3)
    CL Item
    Blood (4)
    CL Item
    Glucose (5)
    CL Item
    Ketones (6)
    Urinalysis, Urine dipstick test, Test Result
    Item
    Result
    text
    C0042014 (UMLS CUI [1,1])
    C0430370 (UMLS CUI [1,2])
    C0456984 (UMLS CUI [1,3])
    Urinalysis, Microscopic urinalysis, Urine Sediment Analysis Measurement
    Item
    Was sedimentary microscopy performed?
    boolean
    C0042014 (UMLS CUI [1,1])
    C0430397 (UMLS CUI [1,2])
    C2700128 (UMLS CUI [1,3])
    Item
    Urinalysis (Microscopy) Test
    text
    C0042014 (UMLS CUI [1,1])
    C0430397 (UMLS CUI [1,2])
    C2700128 (UMLS CUI [1,3])
    Urinalysis, Microscopic urinalysis, Urine Sediment Analysis Measurement
    Code List
    Urinalysis (Microscopy) Test
    CL Item
    WBC (1)
    CL Item
    RBC (2)
    CL Item
    Casts (3)
    CL Item
    Bacteria (4)
    CL Item
    Crystals (5)
    CL Item
    Non squamous cells (6)
    CL Item
    Squamous cells (7)
    Urinalysis, Microscopic urinalysis, Urine Sediment Analysis Measurement, Result
    Item
    Result
    text
    C0042014 (UMLS CUI [1,1])
    C0430397 (UMLS CUI [1,2])
    C2700128 (UMLS CUI [1,3])
    C1274040 (UMLS CUI [1,4])
    Item Group
    Drug and Alcohol Screen
    C0202274 (UMLS CUI-1)
    C0202304 (UMLS CUI-2)
    Urine drug screening, Ethanol measurement, Sampling, Date in time, Time
    Item
    Date and time of sample taken
    datetime
    C0202274 (UMLS CUI [1,1])
    C0202304 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    C0040223 (UMLS CUI [1,5])
    Item
    Cocaine
    text
    C0202274 (UMLS CUI [1,1])
    C0009170 (UMLS CUI [1,2])
    Urine drug screening, Cocaine
    Code List
    Cocaine
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item
    Amphetamines
    text
    C0202274 (UMLS CUI [1,1])
    C0002667 (UMLS CUI [1,2])
    Urine drug screening, Amphetamines
    Code List
    Amphetamines
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item
    Benzodiazepines
    text
    C0202274 (UMLS CUI [1,1])
    C0005064 (UMLS CUI [1,2])
    Urine drug screening, Benzodiazepines
    Code List
    Benzodiazepines
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item
    Cannabis
    text
    C0202274 (UMLS CUI [1,1])
    C0936079 (UMLS CUI [1,2])
    Urine drug screening, Cannabis
    Code List
    Cannabis
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item
    Opiates
    text
    C0202274 (UMLS CUI [1,1])
    C0376196 (UMLS CUI [1,2])
    Urine drug screening, Opiates
    Code List
    Opiates
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Urine drug screening, Barbiturates
    Item
    Barbiturates
    text
    C0202274 (UMLS CUI [1,1])
    C0004745 (UMLS CUI [1,2])
    Item
    Methadone
    text
    C0202274 (UMLS CUI [1,1])
    C0025605 (UMLS CUI [1,2])
    Urine drug screening, Phencyclidine
    Code List
    Methadone
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item
    Alcohol
    text
    C0202304 (UMLS CUI [1])
    Ethanol measurement
    Code List
    Alcohol
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item Group
    Serum Pregnancy Test (Complete for Female Subjects Only)
    C0430060 (UMLS CUI-1)
    Serum pregnancy test (B-HCG), Sampling, Date in time
    Item
    Date sample taken
    date
    C0430060 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Results
    text
    C0430060 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Serum pregnancy test (B-HCG), Result
    Code List
    Results
    CL Item
    Positive  (1)
    CL Item
    Negative (2)
    CL Item
    Not applicable (Women with a documented hysterectomy) (3)
    Item Group
    Randomisation Number
    C0034656 (UMLS CUI-1)
    C0237753 (UMLS CUI-2)
    Randomization, Numbers
    Item
    Record randomisation number.
    integer
    C0034656 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Randomization, Date in time
    Item
    Date of randomisation
    date
    C0034656 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Regimen
    C1276413 (UMLS CUI-1)
    Item
    Regimen
    text
    C1276413 (UMLS CUI [1])
    Therapeutic regimen
    Code List
    Regimen
    CL Item
    Wellbutrin XL/Wellbutrin XL + Ritonavir (1)
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