ID

29499

Beskrivning

Study ID: 104257 Clinical Study ID: CRV104257 Study Title: A randomized, open-label, two period, period balanced, crossover study to estimate the relative bioavailability of an investigational drug compared to Coreg IR in healthy adult 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension Documentation part: Period 2

Nyckelord

Versioner (2)
  1. 2018-04-04 2018-04-04 -
  2. 2018-04-16 2018-04-16 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

4 april 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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Bioavailability of an investigational drug compared to Coreg IR in healthy adults GSK104257

Engelsk

Period 2

1 Formulär  
  1. StudyEvent: ODM
    1. Period 2
Investigational Product
Beskrivning

Investigational Product

Alias
UMLS CUI-1
C0304229
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Planned Timepoint Investigational Product
Beskrivning

Planned Timepoint Investigational Product

Datatyp

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C2348792
Date of Dose of Investigational Product
Beskrivning

Date of Dose of Investigational Product

Datatyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0011008
Time of Dose of Investigational Product
Beskrivning

Time of Dose of Investigational Product

Datatyp

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0040223
Pharmacokinetics - Blood
Beskrivning

Pharmacokinetics - Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
UMLS CUI-3
C0304229
Planned Relative Time, Pharmacokinetics - Blood
Beskrivning

Time Relative to Dosing

Datatyp

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0439564
Date Blood Sample Taken
Beskrivning

Date Blood Sample Taken

Datatyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Time Blood Sample Taken
Beskrivning

Time Blood Sample Taken

Datatyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
Blood Sample Number
Beskrivning

Blood Sample Number

Datatyp

integer

Alias
UMLS CUI [1]
C1299222
Vital signs
Beskrivning

Vital signs

Alias
UMLS CUI-1
C0518766
Date of Vital signs
Beskrivning

Date of Vital signs

Datatyp

date

Alias
UMLS CUI [1]
C2826644
Planned Relative Time of Vital Signs
Beskrivning

Planned Relative Time of Vital Signs

Datatyp

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
Actual Time of Vital Signs
Beskrivning

Actual Time of Vital Signs

Datatyp

time

Alias
UMLS CUI [1]
C2826762
Blood pressure, systolic
Beskrivning

systolic Blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure, diastolic
Beskrivning

diastolic Blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject Position
Beskrivning

Subject Position

Datatyp

integer

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
C0518766
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
12-lead ECG
Beskrivning

12-lead ECG

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1623258
Planned Relative Time of ECG
Beskrivning

Planned Relative Time of ECG

Datatyp

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439564
Start Date of ECG
Beskrivning

Start Date of ECG

Datatyp

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Planned Relative Time ECG
Beskrivning

Planned Relative Time ECG

Datatyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439564
Start Time of ECG
Beskrivning

Start Time of ECG

Datatyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Ventricular Rate
Beskrivning

Ventricular Rate

Datatyp

integer

Måttenheter
  • Beats/min
Alias
UMLS CUI [1,1]
C2189285
UMLS CUI [1,2]
C0430456
Beats/min
PR Interval
Beskrivning

PR Interval

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0429087
UMLS CUI [1,2]
C0430456
msec
QRS Duration
Beskrivning

QRS Duration

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0429025
UMLS CUI [1,2]
C0430456
msec
Uncorrected QT Interval
Beskrivning

Uncorrected QT Interval

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C1287082
UMLS CUI [1,2]
C0430456
msec
QTc Interval
Beskrivning

QTc Interval

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C0430456
msec
Result of the ECG
Beskrivning

Result of the ECG

Datatyp

integer

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C0430456
Electronically Transferred Lab Data
Beskrivning

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0200345
UMLS CUI-2
C0022885
UMLS CUI-3
C1320722
Planned Relative Time Haematology sample taken
Beskrivning

Planned Relative Time Haematology sample taken

Datatyp

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C0439564
Date Haematology sample taken
Beskrivning

Date Haematology sample taken

Datatyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C1302413
Time Haematology sample taken
Beskrivning

Time Haematology sample taken

Datatyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C0040223
Planned Relative Time Clinical Chemistry Sample taken
Beskrivning

Planned Relative Time Clinical Chemistry Sample taken

Datatyp

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0439564
Date Clinical Chemistry Sample taken
Beskrivning

Date Clinical Chemistry Sample taken

Datatyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0011008
Time Clinical Chemistry Sample taken
Beskrivning

Time Clinical Chemistry Sample taken

Datatyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0040223
Planned Relative Time Urinalysis sample taken
Beskrivning

Planned Relative Time Urinalysis sample taken

Datatyp

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200354
UMLS CUI [1,3]
C0439564
Date Urinalysis sample taken
Beskrivning

Date Urinalysis sample taken

Datatyp

date

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
Time Urinalysis sample taken
Beskrivning

Time Urinalysis sample taken

Datatyp

time

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0040223
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Similar models

Period 2

1 Formulär
  1. StudyEvent: ODM
    1. Period 2
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
Planned Timepoint Investigational Product
integer
C0304229 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Planned Timepoint Investigational Product
Code List
Planned Timepoint Investigational Product
CL Item
0 hr (1)
CL Item
12 hrs (2)
Date of Dose of Investigational Product
Item
Date of Dose of Investigational Product
date
C0304229 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of Dose of Investigational Product
Item
Time of Dose of Investigational Product
time
C0304229 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Pharmacokinetics - Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
Item
Planned Relative Time, Pharmacokinetics - Blood
integer
C0005834 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Planned Relative Time
Code List
Planned Relative Time, Pharmacokinetics - Blood
CL Item
Pre-dose (1)
CL Item
+0,25 hrs (2)
CL Item
+0,5 hrs (3)
CL Item
+0,75 hrs (4)
CL Item
+1 hr (5)
CL Item
+1,5 hrs (6)
CL Item
+3 hrs (7)
CL Item
+4 hrs (8)
CL Item
+6 hrs (9)
CL Item
+8 hrs (10)
CL Item
+12 hrs (11)
CL Item
+12,25 hrs (12)
CL Item
+12,5 hrs (13)
CL Item
+12,75 hrs (14)
CL Item
+13 hrs (15)
CL Item
+13,5 hrs (16)
CL Item
+14 hrs (17)
CL Item
+15 hrs (18)
CL Item
+16 hrs (19)
CL Item
+18 hrs (20)
CL Item
+20 hrs (21)
CL Item
+24 hrs (22)
CL Item
+32 hrs (23)
CL Item
+48 hrs (24)
Date Blood Sample Taken
Item
Date Blood Sample Taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time Blood Sample Taken
Item
Time Blood Sample Taken
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Blood Sample Number
Item
Blood Sample Number
integer
C1299222 (UMLS CUI [1])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Date of Vital signs
Item
Date of Vital signs
date
C2826644 (UMLS CUI [1])
Item
Planned Relative Time of Vital Signs
integer
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Planned Relative Time of Vital Signs
Code List
Planned Relative Time of Vital Signs
CL Item
Predose (1)
CL Item
2hr (2)
CL Item
3hr (3)
CL Item
4hr (4)
CL Item
5hr (5)
CL Item
8hr (6)
CL Item
12hr (7)
CL Item
14hr (8)
CL Item
17hr (9)
CL Item
24hr (10)
CL Item
32hr (11)
CL Item
48hr (12)
Actual Time of Vital Signs
Item
Actual Time of Vital Signs
time
C2826762 (UMLS CUI [1])
systolic Blood pressure
Item
Blood pressure, systolic
integer
C0871470 (UMLS CUI [1])
diastolic Blood pressure
Item
Blood pressure, diastolic
integer
C0428883 (UMLS CUI [1])
Item
Subject Position
integer
C1262869 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Subject Position
Code List
Subject Position
CL Item
Supine (1)
CL Item
Sitting (2)
CL Item
Standing (3)
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
12-lead ECG
C0430456 (UMLS CUI-1)
C1623258 (UMLS CUI-2)
Item
Planned Relative Time of ECG
integer
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Timepoint of ECG
Code List
Planned Relative Time of ECG
CL Item
Predose (1)
CL Item
48 hr (2)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Planned Relative Time ECG
Item
Planned Relative Time ECG
text
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Ventricular Rate
Item
Ventricular Rate
integer
C2189285 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
QTc Interval
Item
QTc Interval
float
C0489625 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant  (2)
CL Item
Abnormal- clinically significant (3)
CL Item
No result (not available) (4)
Item Group
Electronically Transferred Lab Data
C0200345 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
Item
Planned Relative Time Haematology sample taken
integer
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Planned Relative Time Haematology sample taken
Code List
Planned Relative Time Haematology sample taken
CL Item
Pre-dose (1)
CL Item
48 hr (2)
Date Haematology sample taken
Item
Date Haematology sample taken
date
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Time Haematology sample taken
Item
Time Haematology sample taken
time
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Planned Relative Time Clinical Chemistry Sample taken
integer
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Planned Relative Time Haematology sample taken
Code List
Planned Relative Time Clinical Chemistry Sample taken
CL Item
Pre-dose (1)
CL Item
48 hr (2)
Date Clinical Chemistry Sample taken
Item
Date Clinical Chemistry Sample taken
date
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time Clinical Chemistry Sample taken
Item
Time Clinical Chemistry Sample taken
time
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Planned Relative Time Urinalysis sample taken
integer
C0042014 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Planned Relative Time Haematology sample taken
Code List
Planned Relative Time Urinalysis sample taken
CL Item
Pre-dose (1)
CL Item
48 hr (2)
Date Urinalysis sample taken
Item
Date Urinalysis sample taken
date
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time Urinalysis sample taken
Item
Time Urinalysis sample taken
time
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
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