ID

39107

Descripción

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

Palabras clave

Versiones (1)
  1. 1/12/19 1/12/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

1 de diciembre de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

Inglés

Period 2 Day 15

1 formularios  
  1. StudyEvent: ODM
    1. Period 2 Day 15
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descripción

Clinical Trial Subject Unique Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Descripción

Date of visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Local Laboratory Result Data (Haematology)
Descripción

Local Laboratory Result Data (Haematology)

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

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

Tipo de datos

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?
Descripción

Laboratory Procedures, Hematology finding, Fasting

Tipo de datos

boolean

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

Laboratory Procedures, Hematology finding

Tipo de datos

text

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

Laboratory Procedures, Hematology finding, Result

Tipo de datos

text

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

Local Laboratory Result Data (Clinical Chemistry)

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

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

Tipo de datos

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?
Descripción

Laboratory Procedures, Clinical, Chemistry, Fasting

Tipo de datos

boolean

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

Laboratory Procedures, Chemistry, Clinical

Tipo de datos

text

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

Laboratory Procedures, Chemistry, Clinical, Result

Tipo de datos

text

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

Urinalysis

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

Urinalysis, Sampling, Date in time, Time

Tipo de datos

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
Descripción

Urinalysis, Urine dipstick test, Result

Tipo de datos

text

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

Urinalysis, Urine dipstick test

Tipo de datos

text

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

Urinalysis, Urine dipstick test, Test Result

Tipo de datos

text

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

Urinalysis, Microscopic urinalysis, Urine Sediment Analysis Measurement

Tipo de datos

boolean

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

Urinalysis, Microscopic urinalysis, Urine Sediment Analysis Measurement

Tipo de datos

text

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

Urinalysis, Microscopic urinalysis, Urine Sediment Analysis Measurement, Result

Tipo de datos

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
Descripción

Drug and Alcohol Screen

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

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

Tipo de datos

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
Descripción

Urine drug screening, Cocaine

Tipo de datos

text

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

Urine drug screening, Amphetamines

Tipo de datos

text

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

Urine drug screening, Benzodiazepines

Tipo de datos

text

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

Urine drug screening, Cannabis

Tipo de datos

text

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

Urine drug screening, Opiates

Tipo de datos

text

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

Urine drug screening, Barbiturates

Tipo de datos

text

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

Urine drug screening, Methadone

Tipo de datos

text

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

Ethanol measurement

Tipo de datos

text

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

Serum Pregnancy Test (Complete for Female Subjects Only)

Alias
UMLS CUI-1
C0430060
Date sample taken
Descripción

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

Tipo de datos

date

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

Serum pregnancy test (B-HCG), Result

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430060
UMLS CUI [1,2]
C1274040
Investigational Product
Descripción

Investigational Product

Alias
UMLS CUI-1
C0304229
Investigational Product
Descripción

Experimental drug

Tipo de datos

text

Alias
UMLS CUI [1]
C0304229
Date of Dose
Descripción

Experimental drug, Dosage, Date in time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Time of Dose
Descripción

Experimental drug, Dosage, Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Dose
Descripción

Experimental drug, Dosage

Tipo de datos

integer

Unidades de medida
  • mg/day
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
mg/day
Unit
Descripción

Experimental drug, Unit of measure

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1519795
Treatment Confirmation
Descripción

Treatment Confirmation

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0750484
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Descripción

Therapeutic Procedure, Confirmation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0750484
If No, record reason(s)
Descripción

Therapeutic Procedure, Wrong, Reason and justification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3827420
UMLS CUI [1,3]
C0566251
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Similar models

Period 2 Day 15

1 formularios
  1. StudyEvent: ODM
    1. Period 2 Day 15
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Visit Date
date
C1320303 (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
Investigational Product
C0304229 (UMLS CUI-1)
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
Experimental drug
Code List
Investigational Product
CL Item
Ritonavir (Morning) (1)
CL Item
Ritonavir (Evening) (2)
Experimental drug, Dosage, Date in time
Item
Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Experimental drug, Dosage, Time
Item
Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Experimental drug, Dosage
Item
Dose
integer
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Item
Unit
text
C0304229 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Experimental drug, Unit of measure
Code List
Unit
CL Item
MG (1)
Item Group
Treatment Confirmation
C0087111 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
Therapeutic Procedure, Confirmation
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
Therapeutic Procedure, Wrong, Reason and justification
Item
If No, record reason(s)
text
C0087111 (UMLS CUI [1,1])
C3827420 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
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