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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