ID

26843

Beschreibung

Study ID: 101468/199 Clinical Study ID: 101468/199 Study Title: An open label study conducted in healthy volunteers to characterize the pharmacokinetics of a new unmarketed formulation of ropinirole 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome Documentation part (Visit Description): Dose Level 1, Day 1

Stichworte

Versionen (1)
  1. 25.10.17 25.10.17 - Julian Varghese
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

25. Oktober 2017

DOI

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Creative Commons BY-NC 3.0
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Pharmacokinetics of a new unmarketed formulation of ropinirole Day 1 101468/199

Englisch

Dose Level 1, Day 1

1 Formulare  
  1. StudyEvent: ODM
    1. Dose Level 1, Day 1
Regimen
Beschreibung

Regimen

Alias
UMLS CUI-1
C1276413
UMLS CUI-2
C0013227
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Regimen, check one:
Beschreibung

Regimen

Datentyp

integer

Alias
UMLS CUI [1,1]
C1276413
UMLS CUI [1,2]
C0013227
UMLS CUI [2]
C0244821
Drug Screen
Beschreibung

Drug Screen

Alias
UMLS CUI-1
C0373483
UMLS CUI-2
C0202274
UMLS CUI-3
C0022885
Date urine sample taken
Beschreibung

Date urine sample taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0011008
Time sample taken
Beschreibung

Time sample taken

Datentyp

time

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0040223
Cocaine
Beschreibung

Cocaine

Datentyp

text

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

Amphetamines

Datentyp

text

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

Benzodiazepines

Datentyp

text

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

Cannabis

Datentyp

text

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

Opiates

Datentyp

text

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

Barbiturates

Datentyp

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0004745
Tricyclic antidepressants
Beschreibung

Tricyclic antidepressants

Datentyp

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0003290
Morphine
Beschreibung

Morphine

Datentyp

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0026549
Morphine Derivatives
Beschreibung

Morphine Derivatives

Datentyp

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0279996
Alcohol Breath Test
Beschreibung

Alcohol Breath Test

Alias
UMLS CUI-1
C0202306
UMLS CUI-2
C0022885
Date sample taken for alcohol breath test
Beschreibung

alcohol breath test date

Datentyp

date

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C0011008
Alcohol breath test Results
Beschreibung

Alcohol breath test Results

Datentyp

text

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C1274040
Pregnancy test
Beschreibung

Pregnancy test

Alias
UMLS CUI-1
C0032976
UMLS CUI-2
C0022885
Date sample taken for Pregnancy test
Beschreibung

Date sample taken

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Pregnancy test Result
Beschreibung

Pregnancy test Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040
12-lead ECG
Beschreibung

12-lead ECG

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1623258
UMLS CUI-3
C0031809
Timepoint of ECG
Beschreibung

Timepoint of ECG

Datentyp

integer

Alias
UMLS CUI [1,1]
C2348792
UMLS CUI [1,2]
C0430456
Start Date of ECG
Beschreibung

Start Date of ECG

Datentyp

date

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

Planned Relative Time ECG

Datentyp

text

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

Start Time of ECG

Datentyp

time

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

Ventricular Rate

Datentyp

integer

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

PR Interval

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0429087
UMLS CUI [1,2]
C0430456
msec
QRS Duration
Beschreibung

QRS Duration

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0429025
UMLS CUI [1,2]
C0430456
msec
Uncorrected QT Interval
Beschreibung

Uncorrected QT Interval

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C1287082
UMLS CUI [1,2]
C0430456
msec
QTc Interval
Beschreibung

QTc Interval

Datentyp

float

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

Result of the ECG

Datentyp

integer

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C0430456
Vital signs
Beschreibung

Vital signs

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0031809
Timepoint of Vital signs
Beschreibung

Timepoint of Vital signs

Datentyp

integer

Alias
UMLS CUI [1]
C0518766
Date
Beschreibung

Of Examination

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Planned Relative Time
Beschreibung

Of Examination

Datentyp

text

Alias
UMLS CUI [1]
C0439564
Actual time
Beschreibung

of Examination

Datentyp

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Systolic Blood pressure
Beschreibung

Systolic Blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood pressure
Beschreibung

Diastolic Blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject Position
Beschreibung

Subject Position

Datentyp

integer

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

Heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Investigational Product
Beschreibung

Investigational Product

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0244821
Investigational Product
Beschreibung

Investigational Product

Datentyp

integer

Alias
UMLS CUI [1]
C0304229
UMLS CUI [2]
C0244821
Date of Dose
Beschreibung

Date of Dose

Datentyp

date

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

Time of Dose

Datentyp

time

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

Dose

Datentyp

float

Maßeinheiten
  • mg/Day
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0304229
mg/Day
Units
Beschreibung

Units

Datentyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0304229
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0304229
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Beschreibung

Treatment confirmation

Datentyp

boolean

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

Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?

Datentyp

text

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
UMLS CUI [2]
C0392360
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Ähnliche Modelle

Dose Level 1, Day 1

1 Formulare
  1. StudyEvent: ODM
    1. Dose Level 1, Day 1
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Regimen
C1276413 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
Regimen, check one:
integer
C1276413 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0244821 (UMLS CUI [2])
Regimen
Code List
Regimen, check one:
CL Item
Ropinirole XR (1)
Item Group
Drug Screen
C0373483 (UMLS CUI-1)
C0202274 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
Date urine sample taken
Item
Date urine sample taken
date
C0200354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time sample taken
Item
Time sample taken
time
C0200354 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Cocaine
text
C0202274 (UMLS CUI [1,1])
C0009170 (UMLS CUI [1,2])
HIV antibodies
Code List
Cocaine
CL Item
Positive (P)
CL Item
Negative (N)
Item
Amphetamines
text
C0202274 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
HIV antibodies
Code List
Amphetamines
CL Item
Positive (P)
CL Item
Negative (N)
Item
Benzodiazepines
text
C0202274 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
HIV antibodies
Code List
Benzodiazepines
CL Item
Positive (P)
CL Item
Negative (N)
Item
Cannabis
text
C0202274 (UMLS CUI [1,1])
C0936079 (UMLS CUI [1,2])
HIV antibodies
Code List
Cannabis
CL Item
Positive (P)
CL Item
Negative (N)
Item
Opiates
text
C0202274 (UMLS CUI [1,1])
C0376196 (UMLS CUI [1,2])
HIV antibodies
Code List
Opiates
CL Item
Positive (P)
CL Item
Negative (N)
Item
Barbiturates
text
C0202274 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
HIV antibodies
Code List
Barbiturates
CL Item
Positive (P)
CL Item
Negative (N)
Item
Tricyclic antidepressants
text
C0202274 (UMLS CUI [1,1])
C0003290 (UMLS CUI [1,2])
HIV antibodies
Code List
Tricyclic antidepressants
CL Item
Positive (P)
CL Item
Negative (N)
Item
Morphine
text
C0202274 (UMLS CUI [1,1])
C0026549 (UMLS CUI [1,2])
HIV antibodies
Code List
Morphine
CL Item
Positive (P)
CL Item
Negative (N)
Item
Morphine Derivatives
text
C0202274 (UMLS CUI [1,1])
C0279996 (UMLS CUI [1,2])
HIV antibodies
Code List
Morphine Derivatives
CL Item
Positive (P)
CL Item
Negative (N)
Item Group
Alcohol Breath Test
C0202306 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
alcohol breath test date
Item
Date sample taken for alcohol breath test
date
C0202306 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Alcohol breath test Results
text
C0202306 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
HIV antibodies
Code List
Alcohol breath test Results
CL Item
Positive (P)
CL Item
Negative (N)
Item Group
Pregnancy test
C0032976 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Date sample taken
Item
Date sample taken for Pregnancy test
boolean
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Pregnancy test Result
text
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Pregnancy test Result
Code List
Pregnancy test Result
CL Item
Positive (P)
CL Item
Negative (N)
CL Item
Not applicable (Not of childbearing potential) (NA)
Item Group
12-lead ECG
C0430456 (UMLS CUI-1)
C1623258 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
Item
Timepoint of ECG
integer
C2348792 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Timepoint of ECG
Code List
Timepoint of ECG
CL Item
Pre-dose (1)
CL Item
+4 hrs (2)
CL Item
Unscheduled (3)
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
Vital signs
C0518766 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Item
Timepoint of Vital signs
integer
C0518766 (UMLS CUI [1])
Timepoint of Vital signs
Code List
Timepoint of Vital signs
CL Item
Pre-dose 1 (1)
CL Item
Pre-dose 2 (2)
CL Item
Pre-dose 3 (3)
CL Item
+2 hrs (4)
CL Item
+4 hrs (5)
CL Item
+6 hrs (6)
CL Item
+12 hrs (7)
CL Item
+24 hrs (8)
CL Item
Unscheduled (9)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Planned Relative Time
Item
Planned Relative Time
text
C0439564 (UMLS CUI [1])
Actual time
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Systolic Blood pressure
Item
Systolic Blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood pressure
Item
Diastolic Blood pressure
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
Standing (2)
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
C0244821 (UMLS CUI-2)
Item
Investigational Product
integer
C0304229 (UMLS CUI [1])
C0244821 (UMLS CUI [2])
Investigational Product
Code List
Investigational Product
CL Item
Ropinirole (1)
Date of Dose
Item
Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time of Dose
Item
Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Dose
Item
Dose
float
C3174092 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Units
Item
Units
text
C1519795 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Route
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Treatment confirmation
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Treatment confirmation
Item
If No, record reason(s)
text
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2])
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