Information:
Error:
ID
42193
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 (2)
- 12/1/19 12/1/19 -
- 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
Copyright Holder
GlaxoSmithKline
Uploaded on
April 13, 2021
DOI
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License
Creative Commons BY-NC 3.0
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Effect of Ritonavir on Bupropion Pharmacokinetics; 103106
Similar models
Screening
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female (2)
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
CL Item
African American/African Heritage (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic/North African Heritage (8)
CL Item
White - White/Caucasian/European Heritage (9)
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (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])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
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])
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])
C0522019 (UMLS CUI [1,2])
Heart rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
12 lead ECG, Start Date
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Item
Planned Relative Time
text
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
CL Item
Screening (1)
12 lead ECG, Start time
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
12 lead ECG, Electrocardiogram: ventricular rate
Item
Ventricular Rate
integer
C0430456 (UMLS CUI [1,1])
C2189285 (UMLS CUI [1,2])
C2189285 (UMLS CUI [1,2])
12 lead ECG, PR interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,2])
12 lead ECG, QRS complex duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,2])
12 lead ECG, QT interval
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,2])
12 lead ECG, Electrocardiogram QT corrected interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
12 lead ECG, Result
Item
Result of the ECG
text
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
Item Group
12-Lead ECG Abnormalities
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C1704258 (UMLS CUI-2)
12 lead ECG, Date in time
Item
Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
12 lead ECG, Time
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Item
Rhythm
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
CL Item
Sinus bradycardia (1)
CL Item
Sinus bradycardia (heart rate 40-50 beats/min) (2)
CL Item
Sinus bradycardia (heart rate 30-39 beats/min) (3)
CL Item
Sinus bradycardia (heart rate < 30 beats/min) (4)
CL Item
Sinus pause (5)
CL Item
Sinus tachycardia (heart rate >100 beats/min) (6)
CL Item
Ectopic supraventricular beats (7)
CL Item
Ectopic supraventricular rhythm (8)
CL Item
Wandering atrial pacemaker (9)
CL Item
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min) (10)
CL Item
Supraventricular tachycardia (heart rate >100 beats/min) (11)
CL Item
Atrial flutter (12)
CL Item
Atrial fibrillation (13)
CL Item
Junctional rhythm (heart rate ≤100 beats/min) (14)
CL Item
Junctional rhythm (15)
CL Item
Junctional tachycardia (heart rate > 100beats/min) (16)
CL Item
Ectopic ventricular beats (17)
CL Item
Ventricular couplets (18)
CL Item
Bigeminy (19)
CL Item
Trigeminy (20)
CL Item
Electrical alternans (21)
CL Item
R on T phenomenon (22)
CL Item
Ventricular fibrillation (23)
CL Item
Idioventricular rhythm (heart rate < 100 beats/min) (24)
CL Item
Sustained ventricular tachycardia (25)
CL Item
Non-sustained ventricular tachycardia (26)
CL Item
Wide QRS Tachycardia (diagnosis unknown) (27)
CL Item
Ventricular tachycardia (28)
CL Item
Monomorphic ventricular tachycardia (29)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (30)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia (31)
CL Item
Artificial pacemaker (32)
CL Item
Other abnormal rhythm (33)
12 lead ECG, Abnormality, Rhythm
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
Item
P-Wave and QRS Morphology
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2216025 (UMLS CUI [1,3])
C0429098 (UMLS CUI [1,4])
C1704258 (UMLS CUI [1,2])
C2216025 (UMLS CUI [1,3])
C0429098 (UMLS CUI [1,4])
Code List
P-Wave and QRS Morphology
CL Item
Left atrial abnormality (P mitrale) (1)
CL Item
Right atrial abnormality (P pulmonale) (2)
CL Item
Right ventricular hypertrophy (3)
CL Item
Intraatrial conduction delay (4)
CL Item
Increased voltage consistent with left ventricular hypertrophy (5)
CL Item
Other morphology (6)
12 lead ECG, Abnormality, electrocardiogram: P wave shifting morphology; Electrocardiogram QRS complex
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2216025 (UMLS CUI [1,3])
C0429098 (UMLS CUI [1,4])
C1704258 (UMLS CUI [1,2])
C2216025 (UMLS CUI [1,3])
C0429098 (UMLS CUI [1,4])
Item
Conduction
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
CL Item
First degree AV block (PR interval > 200 msec) (1)
CL Item
Short PR interval (2)
CL Item
Second degree AV block (Mobitz type 1) (3)
CL Item
Second degree AV block (Mobitz type 2) (4)
CL Item
2:1 AV block (5)
CL Item
Third degree AV block (6)
CL Item
Left axis deviation (QRS axis more negative than -30°) (7)
CL Item
Right axis deviation (QRS axis more positive than +110°) (8)
CL Item
Incomplete right bundle branch block (9)
CL Item
Incomplete left bundle branch block (10)
CL Item
Right bundle branch block (11)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (12)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (13)
CL Item
Left bundle branch block (14)
CL Item
Bifascicular block (15)
CL Item
Non-specific intraventricular conduction delay (QRS ≥ 120 msec) (16)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (17)
CL Item
Prolonged QT interval (18)
CL Item
QT/QTc prolongation ≥ 500 msec (19)
CL Item
AV dissociation (20)
CL Item
Other conduction (21)
12 lead ECG, Abnormality, Cardiac Conduction
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
Item
Myocardial Infarction
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
CL Item
Myocardial infarction, old (1)
CL Item
Myocardial infarction, anterior (2)
CL Item
Myocardial infarction, lateral (3)
CL Item
Myocardial infarction, posterior (4)
CL Item
Myocardial infarction, inferior (5)
CL Item
Myocardial infarction, septal (6)
CL Item
Myocardial infarction, Non-Q wave (7)
CL Item
Other myocardial infarction (8)
12 lead ECG, Abnormality, Myocardial Infarction
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
Item
Depolarisation/Repolarisation (QRS-T)
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [1,3])
C0948857 (UMLS CUI [1,4])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [1,3])
C0948857 (UMLS CUI [1,4])
Code List
Depolarisation/Repolarisation (QRS-T)
CL Item
Non-specific ST-T changes (1)
CL Item
J point elevation (2)
CL Item
ST elevation (3)
CL Item
ST elevation-pericarditis (4)
CL Item
ST depression (5)
CL Item
U waves abnormal (6)
CL Item
T wave inversion (7)
CL Item
T wave peaked (8)
CL Item
T waves flat (9)
CL Item
T waves biphasic (10)
CL Item
Notched T-waves (11)
CL Item
Low QRS voltage (12)
CL Item
T-wave flattening/inversion (13)
CL Item
Other depolarisation/repolarisation (14)
12 lead ECG, Abnormality, Ventricular Depolarization [PE], Electrocardiogram repolarisation abnormality
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [1,3])
C0948857 (UMLS CUI [1,4])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [1,3])
C0948857 (UMLS CUI [1,4])
Item
Other Abnormalities
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
CL Item
Other abnormalities (1)
12 lead ECG, Abnormality, Other
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Disease, Diagnosis
Item
Diagnosis
text
C0012634 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
Disease, Current or past
Item
Current or Past?
text
C0012634 (UMLS CUI [1,1])
C1444635 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,2])
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])
C0456984 (UMLS CUI [1,2])
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])
C0459424 (UMLS CUI [1,2])
Item Group
Local Laboratory Result Data (Haematology)
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
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])
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])
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])
C0474523 (UMLS CUI [1,2])
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])
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)
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])
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])
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])
C0008000 (UMLS CUI [1,2])
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])
C0008000 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
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])
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])
C0430370 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
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])
C0430370 (UMLS CUI [1,2])
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])
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])
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])
C0430397 (UMLS CUI [1,2])
C2700128 (UMLS CUI [1,3])
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])
C0430397 (UMLS CUI [1,2])
C2700128 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Item Group
Serology - HIV, Hepatitis B & C Test
C0019699 (UMLS CUI-1)
C0744837 (UMLS CUI-2)
C0850489 (UMLS CUI-3)
C0744837 (UMLS CUI-2)
C0850489 (UMLS CUI-3)
Serologic tests, Sampling, Date in time
Item
Date sample taken
date
C0036743 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
CL Item
Positive (1)
CL Item
Negative (2)
Item
Hepatitis B surface antigen
text
C0036743 (UMLS CUI [1,1])
C0019168 (UMLS CUI [1,2])
C0019168 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
Item
Hepatitis C antibody
text
C0036743 (UMLS CUI [1,1])
C0201487 (UMLS CUI [1,2])
C0201487 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Drug and Alcohol Screen
C0202274 (UMLS CUI-1)
C0202304 (UMLS CUI-2)
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])
C0202304 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
CL Item
Positive (1)
CL Item
Negative (2)
Item
Amphetamines
text
C0202274 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
C0002667 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
Item
Benzodiazepines
text
C0202274 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
C0005064 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
Item
Cannabis
text
C0202274 (UMLS CUI [1,1])
C0936079 (UMLS CUI [1,2])
C0936079 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
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])
C0004745 (UMLS CUI [1,2])
Item
Phencyclidine
text
C0202274 (UMLS CUI [1,1])
C0031381 (UMLS CUI [1,2])
C0031381 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
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])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Results
text
C0430060 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Not applicable (Women with a documented hysterectomy) (3)
Eligibility Determination
Item
Did the subject meet all the entry criteria?
boolean
C0013893 (UMLS CUI [1])
Health status; Gender; Age
Item
Healthy adult male and female subjects between 18-55 years of age at screening.
boolean
C0018759 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Body mass index
Item
A subject must have a body mass index (BMI) between 18 - 30.
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
Subject must read and write at a level sufficient to provide written informed consent and complete study-related materials.
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential; Contraceptive methods
Item
Subject is male or female and between 18-55 years of age. A female is eligible to enter and participate in the study if she is of: a) non-childbearing potential(i.e., physiologically incapable of pregnancy); or b) child-bearing potential, has a negative pregnancy test (urine or serum)at Screening Visit, and agrees to satisfying one of the following requirements: • abstinence, or • Female sterilization; or • Sterilization of the female’s male partner(s); or • Oral contraception (combined or progestogen only); or • Implants of levonorgestrel; or • Injectable progesterone; or • Any intrauterine device (IUD) with published data showing that the highest expected failure rate is less than 1% per year (not all IUD’s meet this criterion); or • Double-barrier method (any combination of physical and chemical methods); or • Any other method with published data showing that the highest expected failure rate for that method is less than 1% per year.
text
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
C0700589 (UMLS CUI [2])
Abnormality; Disease
Item
Subject has any clinically relevant abnormality identified on the screening medical assessment, laboratory examination or 12-lead ECG, or any other medical condition or circumstance making the volunteer unsuitable for participation in the study. These include any unstable medical disorder; disorders that would interfere with the action, absorption, distribution, metabolism, or excretion of bupropion or ritonavir; disorders which may pose a safety concern or interfere with the accurate assessment of safety or efficacy.
boolean
C1704258 (UMLS CUI [1])
C0012634 (UMLS CUI [2])
C0012634 (UMLS CUI [2])
Mental disorder, Diagnosis; Mental disorder, Medical History; Mental disorder, Family history
Item
Subject has a current diagnosis, previous history, or family history of mania, psychosis, major depression, or other major psychiatric disorder.
boolean
C0004936 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0004936 (UMLS CUI [3,1])
C0241889 (UMLS CUI [3,2])
C0011900 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0004936 (UMLS CUI [3,1])
C0241889 (UMLS CUI [3,2])
Laboratory Procedures, Reference lab test reference range
Item
Subject has a laboratory value outside of the ranges indicated in Appendix 2 that remain elevated on repeat testing.
boolean
C0022885 (UMLS CUI [1,1])
C0883335 (UMLS CUI [1,2])
C0883335 (UMLS CUI [1,2])
Systolic Pressure, Diastolic blood pressure, Heart rate
Item
Subject has a systolic blood pressure outside the range of 90 - 140 mmHg, diastolic blood pressure outside the range of 50 - 90 mmHg and pulse rate at rest >90 and < 45 bpm.
boolean
C0871470 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,3])
C0428883 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,3])
Seizures; Brain Injuries
Item
Subject has current or past history of seizure disorder or brain injury (traumatic or disease-related); or any condition which, in the opinion of the investigator, predisposes to seizure; those treated with other medications or treatment regimens that lower seizure threshold; those undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines or benzodiazepine-like agents). Note: A single childhood febrile seizure is not exclusionary.
boolean
C0036572 (UMLS CUI [1])
C0270611 (UMLS CUI [2])
C0270611 (UMLS CUI [2])
Myocardial Infarction, Medical History; Hypertension diesease, Medical History; Heart Diseases, Unstable status, Medical History
Item
Subject has had any history of a myocardial infarction or has a history of hypertension or unstable heart disease prior to the Screening Visit.
boolean
C0027051 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0020538 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0262926 (UMLS CUI [3,3])
C0262926 (UMLS CUI [1,2])
C0020538 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0262926 (UMLS CUI [3,3])
Gastrointestinal Surgical Procedure, Medical History
Item
Subject has a history of stomach or intestinal surgery, with the exception of appendectomy and cholecystectomy.
boolean
C0524722 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Anorexia nervosa; Bulimia nervosa
Item
Subject has a history or current diagnosis of anorexia nervosa or bulimia.
boolean
C0003125 (UMLS CUI [1,1])
C2267227 (UMLS CUI [1,2])
C2267227 (UMLS CUI [1,2])
Risk, homicidal; At risk for suicide; Homicide attempt; Suicide attempt
Item
Subjects who, in the investigator’s judgement, pose a homicidal or suicidal risk, have ever made a suicide attempt, or have ever been homicidal.
boolean
C0035647 (UMLS CUI [1,1])
C0745031 (UMLS CUI [1,2])
C0563664 (UMLS CUI [2])
C0277662 (UMLS CUI [3])
C0038663 (UMLS CUI [4])
C0745031 (UMLS CUI [1,2])
C0563664 (UMLS CUI [2])
C0277662 (UMLS CUI [3])
C0038663 (UMLS CUI [4])
bupropion Hydrochloride, Previous; Ritonavir, Previous
Item
Subjects who have taken bupropion hydrochloride or ritonavir within the last 6 months.
boolean
C0700563 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0292818 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0205156 (UMLS CUI [1,2])
C0292818 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Alcohol consumption; Substance Dependence
Item
Subject has a history of regular alcohol consumption exceeding an average of 7 drinks/week (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) or drug addiction within 6 months of screening.
boolean
C0001948 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
C0038580 (UMLS CUI [2])
Urine drug screening, Positive; Substance Use Disorders, Medical History; Alcohol abuse; Medical History
Item
Subject has a positive urine test at screening for illicit drug use and/ or a history of alcohol or substance abuse or dependence within the past 12 months. Subject has a positive urine test for alcohol at the Screening visit. Note - subjects must be told to avoid consumption of alcoholic beverages for at least 8 hours prior to their (screening) clinic visit.
boolean
C0202274 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
C0038586 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0085762 (UMLS CUI [3,1])
C0262926 (UMLS CUI [3,2])
C1446409 (UMLS CUI [1,2])
C0038586 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0085762 (UMLS CUI [3,1])
C0262926 (UMLS CUI [3,2])
Study Subject Participation Status
Item
Subject has had treatment with an invstigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
boolean
C2348568 (UMLS CUI [1])
Cytochrome P450 3A4 Inducer; Cytochrome P450 3A4 Inhibitor
Item
Subject has used any agents that are known to inhibit or induce P450 enzymes (see appendix 3) within 14 days prior to the first dose of study medication, including grapefruit-containing products and St. John’s Wort.
boolean
C3830625 (UMLS CUI [1])
C3830624 (UMLS CUI [2])
C3830624 (UMLS CUI [2])
Concomitant Agent
Item
Subject has used any other prescription or non-prescription drugs, including hormone replacement therapy, vitamins, herbal and dietary supplements within fourteen days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Acetaminophen (≤2 g/day) will be permitted during the study for analgesia. Subjects may continue to use their previously-prescribed oral, implantable, or injectable contraceptives.
boolean
C2347852 (UMLS CUI [1])
Wellbutrin SR, Hypersensitivity
Item
Subject has a history of hypersensitivity to WELLBUTRIN XL or any of its constituents or closely related compounds.
boolean
C0724393 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,2])
Ritonavir, Hypersensitivity
Item
Subject has a history of hypersensitivity to ritonavir or any of its constituents or closely related compounds.
boolean
C0292818 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,2])
Heparin, Hypersensitivity, Medical History; Heparin-induced Thrombocytopenia, Medical History
Item
Subject has a history of sensitivity to heparin or heparin-induced thrombocytopenia.
boolean
C0019134 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0272285 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0020517 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0272285 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
Collection of blood specimen for laboratory procedure
Item
Subject has had blood collection of greater than 500mL within 56 days prior to study start.
boolean
C0005834 (UMLS CUI [1])
Pregnancy; Breast Feeding
Item
Subject is a pregnant or nursing woman. A serum pregnancy test will be obtained for all women at screening and prior to dosing in Period 1 to confirm eligibility. By exception, pregnancy testing will not be required for women with a documented hysterectomy.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Contraceptive methods, Unwilling
Item
Subject is unwilling or unable to use an appropriate method of contraception from at least 14 days prior to study medication administration until completion of the final follow-up visit.
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,2])
HIV Seropositivity; Hepatitis B positive; Hepatitis C positive
Item
Subject test positive to HIV, Hepatitis B or Hepatitis C test screening.
boolean
C0019699 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Protocol Compliance
Item
Subject is unwilling to adhere to the study Lifestyle Guidelines as described in Section 6.1.
boolean
C0525058 (UMLS CUI [1])
Compliance behavior
Item
Subject is, in the opinion of the investigator, likely to be non-compliant with the study visit schedule or with the study procedures (e.e. illiteracy, planned vacations, planned hospitalizations during the course of the study, poor medicine compliance).
boolean
C1321605 (UMLS CUI [1])
Tobacco use; Nicotine Use Disorder
Item
History or evidence of habitual tobacco or nicotine-containing products within 3 months of screening.
boolean
C0543414 (UMLS CUI [1])
C0376384 (UMLS CUI [2])
C0376384 (UMLS CUI [2])