ID

39098

Beschreibung

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

Stichworte

Versionen (1)
  1. 01.12.19 01.12.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

1. Dezember 2019

DOI

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Lizenz

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

Englisch

Baseline Day -1

1 Formulare  
  1. StudyEvent: ODM
    1. Baseline Day -1
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Physical Examination
Beschreibung

Physical Examination

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

Physical Examination

Datentyp

boolean

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

Physical Examination, Test Result

Datentyp

text

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

Physical Examination, Abnormal result

Datentyp

text

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

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Beschreibung

Vital Signs Date

Datentyp

date

Alias
UMLS CUI [1]
C2826644
Planned Relative Time
Beschreibung

Vital signs, Relative time, Planned

Datentyp

text

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

Vital Signs Time

Datentyp

time

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

Systolic Pressure, Semi-erect

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
mm[Hg]
Blood Pressure - Semi-supine - Diastolic
Beschreibung

Diastolic blood pressure, Semi-erect

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
mm[Hg]
Heart Rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Local Laboratory Result Data (Haematology)
Beschreibung

Local Laboratory Result Data (Haematology)

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

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

Datentyp

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?
Beschreibung

Laboratory Procedures, Hematology finding, Fasting

Datentyp

boolean

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

Laboratory Procedures, Hematology finding

Datentyp

text

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

Laboratory Procedures, Hematology finding, Result

Datentyp

text

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

Local Laboratory Result Data (Clinical Chemistry)

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

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

Datentyp

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?
Beschreibung

Laboratory Procedures, Clinical, Chemistry, Fasting

Datentyp

boolean

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

Laboratory Procedures, Chemistry, Clinical

Datentyp

text

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

Laboratory Procedures, Chemistry, Clinical, Result

Datentyp

text

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

Urinalysis

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

Urinalysis, Sampling, Date in time, Time

Datentyp

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
Beschreibung

Urinalysis, Urine dipstick test, Result

Datentyp

text

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

Urinalysis, Urine dipstick test

Datentyp

text

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

Urinalysis, Urine dipstick test, Test Result

Datentyp

text

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

Urinalysis, Microscopic urinalysis, Urine Sediment Analysis Measurement

Datentyp

boolean

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

Urinalysis, Microscopic urinalysis, Urine Sediment Analysis Measurement

Datentyp

text

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

Urinalysis, Microscopic urinalysis, Urine Sediment Analysis Measurement, Result

Datentyp

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
Beschreibung

Drug and Alcohol Screen

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

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

Datentyp

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
Beschreibung

Urine drug screening, Cocaine

Datentyp

text

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

Urine drug screening, Amphetamines

Datentyp

text

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

Urine drug screening, Benzodiazepines

Datentyp

text

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

Urine drug screening, Cannabis

Datentyp

text

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

Urine drug screening, Opiates

Datentyp

text

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

Urine drug screening, Barbiturates

Datentyp

text

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

Urine drug screening, Methadone

Datentyp

text

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

Ethanol measurement

Datentyp

text

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

Serum Pregnancy Test (Complete for Female Subjects Only)

Alias
UMLS CUI-1
C0430060
Date sample taken
Beschreibung

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

Datentyp

date

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

Serum pregnancy test (B-HCG), Result

Datentyp

text

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

Randomisation Number

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

Randomization, Numbers

Datentyp

integer

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

Randomization, Date in time

Datentyp

date

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

Regimen

Alias
UMLS CUI-1
C1276413
Regimen
Beschreibung

Therapeutic regimen

Datentyp

text

Alias
UMLS CUI [1]
C1276413
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Ähnliche Modelle

Baseline Day -1

1 Formulare
  1. StudyEvent: ODM
    1. Baseline Day -1
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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