ID

39178

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2019-12-08 2019-12-08 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

8 december 2019

DOI

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Licens

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

Engelsk

Period 2 Day 24

1 Formulär  
  1. StudyEvent: ODM
    1. Period 2 Day 24
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Clinical Trial Subject Unique Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Vital Signs
Beskrivning

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Beskrivning

Vital Signs Date

Datatyp

date

Alias
UMLS CUI [1]
C2826644
Planned Relative Time
Beskrivning

Vital signs, Relative time, Planned

Datatyp

text

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

Vital Signs Time

Datatyp

time

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

Systolic Pressure, Semi-erect

Datatyp

integer

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

Diastolic blood pressure, Semi-erect

Datatyp

integer

Måttenheter
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
mm[Hg]
Heart Rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Investigational Product
Beskrivning

Investigational Product

Alias
UMLS CUI-1
C0304229
Investigational Product
Beskrivning

Experimental drug

Datatyp

text

Alias
UMLS CUI [1]
C0304229
Date of Dose
Beskrivning

Experimental drug, Dosage, Date in time

Datatyp

date

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

Experimental drug, Dosage, Time

Datatyp

time

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

Experimental drug, Dosage

Datatyp

integer

Måttenheter
  • mg/day
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
Unit
Beskrivning

Experimental drug, Unit of measure

Datatyp

text

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

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?
Beskrivning

Therapeutic Procedure, Confirmation

Datatyp

boolean

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

Therapeutic Procedure, Wrong, Reason and justification

Datatyp

text

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

Pharmacokinetics - Blood

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

Pharmacokinetic aspects, Blood, Relative time, Blood

Datatyp

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
Beskrivning

Pharmacokinetic aspects, Blood, Sampling, Date in time

Datatyp

date

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

Pharmacokinetic aspects, Blood, Time

Datatyp

time

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

Pharmacokinetic aspects, Sampling

Datatyp

boolean

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

Pharmacokinetic aspects, Sample identification number

Datatyp

text

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

Period 2 Day 24

1 Formulär
  1. StudyEvent: ODM
    1. Period 2 Day 24
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (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
Pre-dose (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
Ritonavir (Morning) (1)
CL Item
WELLBUTRIN XL (2)
CL Item
Ritonavir (Evening) (3)
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])
Item
Dose
integer
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Experimental drug, Dosage
Code List
Dose
CL Item
600 (1)
CL Item
150 (2)
CL Item
600 (3)
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
101 (1)
CL Item
102 (2)
CL Item
103 (3)
CL Item
104 (4)
CL Item
105 (5)
CL Item
106 (6)
CL Item
107 (7)
CL Item
108 (8)
CL Item
109 (9)
CL Item
110 (10)
CL Item
111 (11)
CL Item
112 (12)
CL Item
113 (13)
CL Item
114 (14)
CL Item
115 (15)
CL Item
116 (16)
CL Item
117 (17)
CL Item
118 (18)
CL Item
119 (19)
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