ID

26843

Description

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

Mots-clés

Versions (1)
  1. 25/10/2017 25/10/2017 - Julian Varghese
Détendeur de droits

GlaxoSmithKline

Téléchargé le

25 octobre 2017

DOI

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Licence

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

Anglais

Dose Level 1, Day 1

1 Formulaires  
  1. StudyEvent: ODM
    1. Dose Level 1, Day 1
Regimen
Description

Regimen

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

Subject Identifier

Type de données

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Type de données

date

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

Regimen

Type de données

integer

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

Drug Screen

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

Date urine sample taken

Type de données

date

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

Time sample taken

Type de données

time

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

Cocaine

Type de données

text

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

Amphetamines

Type de données

text

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

Benzodiazepines

Type de données

text

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

Cannabis

Type de données

text

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

Opiates

Type de données

text

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

Barbiturates

Type de données

text

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

Tricyclic antidepressants

Type de données

text

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

Morphine

Type de données

text

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

Morphine Derivatives

Type de données

text

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

Alcohol Breath Test

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

alcohol breath test date

Type de données

date

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

Alcohol breath test Results

Type de données

text

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

Pregnancy test

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

Date sample taken

Type de données

boolean

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

Pregnancy test Result

Type de données

text

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

12-lead ECG

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

Timepoint of ECG

Type de données

integer

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

Start Date of ECG

Type de données

date

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

Planned Relative Time ECG

Type de données

text

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

Start Time of ECG

Type de données

time

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

Ventricular Rate

Type de données

integer

Unités de mesure
  • Beats/min
Alias
UMLS CUI [1,1]
C2189285
UMLS CUI [1,2]
C0430456
Beats/min
PR Interval
Description

PR Interval

Type de données

float

Unités de mesure
  • msec
Alias
UMLS CUI [1,1]
C0429087
UMLS CUI [1,2]
C0430456
msec
QRS Duration
Description

QRS Duration

Type de données

float

Unités de mesure
  • msec
Alias
UMLS CUI [1,1]
C0429025
UMLS CUI [1,2]
C0430456
msec
Uncorrected QT Interval
Description

Uncorrected QT Interval

Type de données

float

Unités de mesure
  • msec
Alias
UMLS CUI [1,1]
C1287082
UMLS CUI [1,2]
C0430456
msec
QTc Interval
Description

QTc Interval

Type de données

float

Unités de mesure
  • msec
Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C0430456
msec
Result of the ECG
Description

Result of the ECG

Type de données

integer

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

Vital signs

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

Timepoint of Vital signs

Type de données

integer

Alias
UMLS CUI [1]
C0518766
Date
Description

Of Examination

Type de données

date

Alias
UMLS CUI [1]
C0011008
Planned Relative Time
Description

Of Examination

Type de données

text

Alias
UMLS CUI [1]
C0439564
Actual time
Description

of Examination

Type de données

time

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

Systolic Blood pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood pressure
Description

Diastolic Blood pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject Position
Description

Subject Position

Type de données

integer

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

Heart rate

Type de données

integer

Unités de mesure
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Investigational Product
Description

Investigational Product

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

Investigational Product

Type de données

integer

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

Date of Dose

Type de données

date

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

Time of Dose

Type de données

time

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

Dose

Type de données

float

Unités de mesure
  • mg/Day
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0304229
mg/Day
Units
Description

Units

Type de données

text

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

Route

Type de données

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?
Description

Treatment confirmation

Type de données

boolean

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

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

Type de données

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 Formulaires
  1. StudyEvent: ODM
    1. Dose Level 1, Day 1
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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