ID

39099

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

Period 1 Day 1

1 forms  
  1. StudyEvent: ODM
    1. Period 1 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
Visit Date
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
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
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
Investigational Product
Description

Experimental drug

Data type

text

Alias
UMLS CUI [1]
C0304229
Date of Dose
Description

Experimental drug, Dosage, Date in time

Data type

date

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

Experimental drug, Dosage, Time

Data type

time

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

Experimental drug, Dosage

Data type

integer

Measurement units
  • mg/day
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
mg/day
Unit
Description

Experimental drug, Unit of measure

Data type

text

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

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?
Description

Therapeutic Procedure, Confirmation

Data type

boolean

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

Therapeutic Procedure, Wrong, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3827420
UMLS CUI [1,3]
C0566251
Pharmacokinetics - Blood
Description

Pharmacokinetics - Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Description

Pharmacokinetic aspects, Blood, Relative time, Blood

Data type

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0439564
UMLS CUI [1,4]
C1301732
Date Sample Taken
Description

Pharmacokinetic aspects, Blood, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Actual Time
Description

Pharmacokinetic aspects, Blood, Time

Data type

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0040223
5mL Sample, Check if Taken
Description

Pharmacokinetic aspects, Sampling

Data type

boolean

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
Sample Number
Description

Pharmacokinetic aspects, Sample identification number

Data type

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C1299222
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Similar models

Period 1 Day 1

1 forms
  1. StudyEvent: ODM
    1. Period 1 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])
Date of visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
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
Investigational Product
C0304229 (UMLS CUI-1)
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
Experimental drug
Code List
Investigational Product
CL Item
WELLBUTRIN XL (1)
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])
Item Group
Pharmacokinetics - Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
text
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Pharmacokinetic aspects, Blood, Relative time, Blood
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
+1 hr (2)
CL Item
+2 hrs (3)
CL Item
+3 hrs (4)
CL Item
+4 hrs (5)
CL Item
+5 hrs (6)
CL Item
+6 hrs (7)
CL Item
+8 hrs (8)
CL Item
+10 hrs (9)
CL Item
+12 hrs (10)
CL Item
+16 hrs (11)
CL Item
+24 hrs (12)
CL Item
+36 hrs (13)
CL Item
+48 hrs (14)
CL Item
+72 hrs (15)
CL Item
+96 hrs (16)
CL Item
+120 hrs (17)
CL Item
+144 hrs (18)
CL Item
+168 hrs (19)
Pharmacokinetic aspects, Blood, Sampling, Date in time
Item
Date Sample Taken
date
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Pharmacokinetic aspects, Blood, Time
Item
Actual Time
time
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pharmacokinetic aspects, Sampling
Item
5mL Sample, Check if Taken
boolean
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
Item
Sample Number
text
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
Pharmacokinetic aspects, Sample identification number
Code List
Sample Number
CL Item
001 (1)
CL Item
002 (2)
CL Item
003 (3)
CL Item
004 (4)
CL Item
005 (5)
CL Item
006 (6)
CL Item
007 (7)
CL Item
008 (8)
CL Item
009 (9)
CL Item
010 (10)
CL Item
011 (11)
CL Item
012 (12)
CL Item
013 (13)
CL Item
014 (14)
CL Item
015 (15)
CL Item
016 (16)
CL Item
017 (17)
CL Item
018 (18)
CL Item
019 (19)
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