ID

26616

Descripción

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

Palabras clave

Versiones (1)
  1. 22/10/17 22/10/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

22 de octubre de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

Inglés

Dose Level 1, Day 1

1 formularios  
  1. StudyEvent: ODM
    1. Dose Level 1, Day 1
Regimen
Descripción

Regimen

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

Subject Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Descripción

Visit Date

Tipo de datos

date

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

Regimen

Tipo de datos

integer

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

Drug Screen

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

Date urine sample taken

Tipo de datos

date

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

Time sample taken

Tipo de datos

time

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

Cocaine

Tipo de datos

text

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

Amphetamines

Tipo de datos

text

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

Benzodiazepines

Tipo de datos

text

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

Cannabis

Tipo de datos

text

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

Opiates

Tipo de datos

text

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

Barbiturates

Tipo de datos

text

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

Tricyclic antidepressants

Tipo de datos

text

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

Morphine

Tipo de datos

text

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

Morphine Derivatives

Tipo de datos

text

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

Alcohol Breath Test

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

alcohol breath test date

Tipo de datos

date

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

Alcohol breath test Results

Tipo de datos

text

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

Pregnancy test

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

Date sample taken

Tipo de datos

boolean

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

Pregnancy test Result

Tipo de datos

text

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

12-lead ECG

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

Timepoint of ECG

Tipo de datos

integer

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

Start Date of ECG

Tipo de datos

date

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

Planned Relative Time ECG

Tipo de datos

text

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

Start Time of ECG

Tipo de datos

time

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

Ventricular Rate

Tipo de datos

integer

Unidades de medida
  • Beats/min
Alias
UMLS CUI [1,1]
C2189285
UMLS CUI [1,2]
C0430456
Beats/min
PR Interval
Descripción

PR Interval

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0429087
UMLS CUI [1,2]
C0430456
msec
QRS Duration
Descripción

QRS Duration

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0429025
UMLS CUI [1,2]
C0430456
msec
Uncorrected QT Interval
Descripción

Uncorrected QT Interval

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C1287082
UMLS CUI [1,2]
C0430456
msec
QTc Interval
Descripción

QTc Interval

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C0430456
msec
Result of the ECG
Descripción

Result of the ECG

Tipo de datos

integer

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

Vital signs

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

Timepoint of Vital signs

Tipo de datos

integer

Alias
UMLS CUI [1]
C0518766
Date
Descripción

Of Examination

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Planned Relative Time
Descripción

Of Examination

Tipo de datos

text

Alias
UMLS CUI [1]
C0439564
Actual time
Descripción

of Examination

Tipo de datos

time

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

Systolic Blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood pressure
Descripción

Diastolic Blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject Position
Descripción

Subject Position

Tipo de datos

integer

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

Heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Investigational Product
Descripción

Investigational Product

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

Investigational Product

Tipo de datos

integer

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

Date of Dose

Tipo de datos

date

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

Time of Dose

Tipo de datos

time

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

Dose

Tipo de datos

float

Unidades de medida
  • mg/Day
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0304229
mg/Day
Units
Descripción

Units

Tipo de datos

text

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

Route

Tipo de datos

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?
Descripción

Treatment confirmation

Tipo de datos

boolean

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

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

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
UMLS CUI [2]
C0392360
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Similar models

Dose Level 1, Day 1

1 formularios
  1. StudyEvent: ODM
    1. Dose Level 1, Day 1
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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